The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy,punctures, etc.) and
Allengers Medical Systems Limited Mr. Sanjeev K. Marjara Director Technical Bhankharpur, Mubarakpur Road Derabassi, Distt Mohali, Punjab 140507 INDIA October 16, 2019 Re: K192541 Trade/Device Name: DigiX FDX Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 10, 2019 Received: September 16, 2019 Dear Mr. Sanjeev Marjara: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov Doc ID# 04017.04.07 K192541 Mr. Sanjeev K. Marjara Page 2 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Enclosure For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K192541 Device Name DigiX FDX Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. Indications for Use (Describe) The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/ supine position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF Allengers Medical Systems Limited 510(k) SUMMARY K192541 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR 807.92 1. Classification and Device Name Device (trade) Name: DigiX FDX Common/usual Name: Digital X-Ray imaging system Classification Name: Stationary X-Ray system, Class II Classification: 21 CFR 892.1680 Classification Name: Stationary X-Ray System Classification Panel: Radiology Device Class: Class II Device Code: KPR 510(K) Submission: Special 2. Contact Person and Address Company Name: Allengers Medical Systems Limited Address: Telephone No: Bhankharpur, Mubarakpur Road, Derabassi, Distt Mohali-140507 India +91 1762-272600, +91 9872980168 Contact Person: Sanjeev K. Marjara Date Prepared: 10 September 2019 3. Predicate Device: Predicate Device: DigiX FDX Classification: 21 CFR 892.1680 Classification Name: Stationary X-Ray system Common/usual Name: Digital X-Ray imaging system Device Class: Class II 510(K) Number: K162529 Product Code: KPR Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-1 Section 5-0 Allengers Medical Systems Limited 4. Secondary Predicate Device: Secondary Device: Ysio Classification: 21 CFR 892.1680 Classification Name: Stationary X-Ray system Common/usual Name: Digital X-Ray imaging system Device Class: Class II 510(K) Number: K081722 Product Code: KPR Allengers supplies digital detectors that have been previously cleared by the FDA or tested and evaluated per Guidance for the Submission of 510(k)s for Solid State XRay Imaging Devices. Table 1 provides the list of solid state X-Ray image detectors used in device *Table 1 List of Solid State X-Ray Image Detectors Solid State X-Ray Image Detectors 510(K) Numbers Varex PaxScan 4343R Fixed K130318 Varex PaxScan 4343R v3 Fixed K183541 Thales Pixium RAD 4343 C-E (Fixed) K181279 Varex Paxscan 4343CB - Fixed K190373 IRAY VENU 1717X Fixed -- Varex PaxScan 4336R Portable K130318 Varex (Perkin Elmer ) XRPAD 4343F K142698 Varex PaxScan 4336W Wireless K142049 Varex (Perkin Elmer) XRPAD 4336 Wireless K140551 Varex PaxScan 4336W v4 Wireless K183541 Varex PaxScan 4336W v4 + Wireless -- Thales Pixium 3543 DR-CS (Wireless) K182517 IRAY VENU 1417V (Wireless) -- * All the above mentioned Solid State X-Ray Image Detectors (Digital detectors) can be used with Dual Energy Subtraction feature. Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-2 Section 5-0 Allengers Medical Systems Limited 5. Device Description: The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging. The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor. The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections. The following in Table 2 are the specific components for various configurations of the system. A complete system will consist of a selection of one of the devices in each category. Table 2 Combination Detail Component Manufacture Model Ceiling Mounted X-Ray Tube Suspension Allengers CSA FDX Vertical Bucky Stand Vertical Bucky Stand Allengers Allengers VBS ADV VBS M XL Patient Table Fixed Patient Table Fixed Patient Table Fixed Patient Table Mobile Patient Table Mobile Patient Table Mobile Allengers Allengers Allengers Allengers Allengers Allengers Floatex ADV Floatex Floatex XL MobiT 6C MobiT 4C MobiT C X-Ray Generator X-Ray Generator Allengers Allengers XGEN-80R XGEN-65R X-Ray Tube X-Ray Tube X-Ray Tube X-Ray Tube X-Ray Tube Varex Varex Varex Varex Varex A192 A292 G292 G1092 RAD14 Beam Limiting Device Ralco R225 ACS Solid State X-Ray Image Detector Fixed Solid State X-Ray Image Detector Fixed Solid State X-Ray Image Detector Portable Wired Solid State X-Ray Image Detector Portable Wired Solid State X-Ray Image Detector Fixed Solid State X-Ray Image Detector Fixed Varex Varex Varex Varex (Perkin Elmer) Varex Thales PaxScan 4343R PaxScan 4343R v3 PaxScan 4336R XRPAD 4343F PaxScan 4343CB Pixium Rad 4343 CE Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-3 Section 5-0 Allengers Medical Systems Limited Solid State X-Ray Image Detector Fixed Solid State X-Ray Image Detector WiFi Solid State X-Ray Image Detector WiFi Solid State X-Ray Image Detector WiFi Solid State X-Ray Image Detector WiFi Solid State X-Ray Image Detector WiFi Solid State X-Ray Image Detector WiFi IRAY Varex Varex Varex Varex (Perkin Elmer) Thales IRAY VENU 1717X PaxScan 4336W PaxScan 4336W V4 PaxScan 4336W V4 + XRPAD 4336 Pixium 3543DR-CS MARS 1417V 6. Technological Characteristics Comparison to Predicate Device: The Subject device DigiX FDX design is based on the Allenger's DigiX FDX (K162529) including the system control, Indication for use and mechanical design. The modifications do not affect the intended use of the device the subject device and predicate device are based on the following same fundamental scientific technologies elements: Energy emission to the patient X-Ray Power requirement, Environmental requirement Mechanism to generate X-Ray Mechanism to acquire, process and store image data Use of the hardware components Use of software processing This 510(k) submission describes some modifications to the previously cleared predicate devices the DigiX FDX (K162529). The changes to the predicate DigiX FDX (K162529) include: System Software Synergy DR FDX Synergy DR FDX comparable to ECOM DROC (K130883) added with same functionality along with below said additional features. Operating System: Updated operating system from Windows 7 to Windows 10 Automatic Stitching: Image stitching is the process of overlapping two or more images taken at different viewpoints and different times to generate a wider viewing panoramic image. **Dual Energy Subtraction: Dual energy subtraction (DES) radiography, a new added feature for software Synergy DR FDX, is a technique which aims to improve the diagnostic value of an X-Ray by separating soft tissue from bones, producing two different images. ** Dual Energy Subtraction feature can be used with all the Solid State X-Ray Image detectors (Digital detectors) listed in table 1 of this 510(k) summary. Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-4 Section 5-0 Allengers Medical Systems Limited Component Change X-Ray Tube : RAD-14 (Make : Varex Imaging) is added 43x36cm Wireless Detectors are added (Listed below), Paxscan 4336W v4 manufactured by Varex Imaging Pixium 3543 DR-CS manufactured by Thales. MARS 1417V manufactured by IRAY technology. 43x43cm Fixed Detectors are added (Listed below), Paxscan 4343R v3 manufactured by Varex imaging Pixium Rad 4343 C-E manufactured by Thales VENU 17171X manufactured by IRAY technology. Paxscan 4343CB manufactured by Varex Imaging. Wireless IR Remote (Optional) added. Monitor with 19" or more in size (touch and Non touch) added. Patient Table: Minor changes in mechanical dimensions and increase the load carrying capacity of patient tables. Others Change EMC (Electromagnetic Compatibility) was tested according to IEC ed. 4.0. Combination Name change (Refer Table 4 for more detail) Brand Name M/s Varian to M/s Varex imaging (FPD & X-Ray Tube Manufacturer) 7. Indications for Use: The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position. The DigiX FDX System is not meant for mammography. The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes. Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-5 Section 5-0 Allengers Medical Systems Limited 8. Substantial Equivalence: The DigiX FDX radiographic X-Ray system is substantially equivalent to the commercially available primary predicate Allenger's DigiX FDX Cleared March 3, 2017 with K162529 Mechanical dimensions was slightly change, however the changes doesn't impact the intended use of device. Table 3 provides primary and secondary predicate comparable information Table 3 Predicate Device Comparable Properties Predicate Device(s) Name and Manufacture Primary Predicate Device DigiX FDX Product Code: KPR Address: Allengers Medical Systems Ltd. Bhankharpur, Mubarakpur Road, Derabassi, Distt Mohali-140507 India Secondary Predicate Device: Ysio Product Code: KPR Address: Siemens Medical Solutions USA, Inc, 51 valley stream, Parkway E-50, Malvern PA, 193351406 510(K) Number K162529 K081722 Clearance Date 3/3/2017 Comparable Properties Technical Design Mechanical Design System Software 8/25/2008 Technical Design Mechanical Design System Software Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-6 Section 5-0 Allengers Medical Systems Limited Table 4: Functional and Specification Differences Feature 1. 510(K) Subject Device DigiX FDX Predicate 1 DigiX FDX Predicate 2 Siemens Ysio Comparison Results 510(K) K192541 K162529 K081722 Same 2. Classification Classification 21 CFR 892.1680 21 CFR 892.1680 21 CFR 892.1680 Same Clinical Characteristics 3. Indication for Use The DigiX FDX The DigiX FDX radiographic systems radiographic are used in hospitals, systems are used clinics and medical in hospitals, clinics practices. DigiX FDX and medical enables radiographic practices. DigiX exposure of the whole FDX enables body including: Skull, radiographic chest, abdomen, and exposure of the extremities and may be whole body used on pediatric, adult including: Skull, and bariatric patients. It chest, abdomen, can also be used for and extremities intravenous, small and may be used interventions (like on pediatric, adult biopsy, punctures, etc.) and bariatric and emergency patients. It can Indications for (trauma critical ill) also be used for Use applications. intravenous, small Exposure may be taken interventions (like with the Patient's biopsy, punctures, sitting, standing, or in etc.) and the prone/supine emergency position. (trauma critical ill) applications. The DigiX FDX System Exposure may be is not meant for taken with the mammography. Patient's sitting, standing, or in the The DigiX FDX uses an prone/supine integrated or portable position. or fixed or Wi-Fi digital detector for generating The DigiX FDX diagnostic images by System is not converting X-Ray into meant for electronics signals. mammography. The Ysio (New RAD Family) systems are the radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio system is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting X-Rays into electronic signals. Ysio is also designed to be used Same as predicate 1 Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-7 Section 5-0 Allengers Medical Systems Limited DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes. The DigiX FDX with conventional uses an integrated film/screen or or portable or fixed Computed or Wi-Fi digital Radiography (CR) detector for Cassettes generating diagnostic images by converting X- Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes. Technical Characteristics 4. Ceiling Mounted X-Ray Tube Suspension Model CSA FDX CSAAdv & CSAFDX Longitudinal travel 300 cm 300 cm Transverse travel 200 cm 200 cm Ysio 346 cm 220 cm Vertical travel 150 cm 150 cm 190 cm Tube rotation (horiz.) ±180° Tube rotation (vert.) ±180° Fully automated Yes Digital Readout Yes 5. Vertical Bucky Stand Model VBS ADV ±180° ±180° Yes Yes VBSAdv ±180° ±180° Yes Yes BWS with Max static Vertical travel 125 cm Model VBS M XL 125 cm VBS MXL 145 cm BWS wi-D Vertical travel 162 cm 162 cm 141 cm 6. Patient Table Model Floatex XL Type 4-way floating top Longitudinal travel Transverse travel 95 cm 25 cm FloatexXL 4-way floating Top 95 cm, 25 cm, Bucky Table 4-way floating top NA NA Same as predicate 1 Same as predicate 1 Same as predicate 1 Same Same Same Same Same as predicate 1 Same as predicate 1 Same Same Same Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-8 Section 5-0 Allengers Medical Systems Limited Table top locking Maximum patient capacity Electromagnetic 250 kg (551 lbs) Electromagnetic Electromagnetic 200 kg (440 lbs) 300 kg (660 lbs) Same Similar Functionality (Note 1) Model Type Longitudinal travel Floatex ADV 6-way floating top 95 cm Transverse travel 25 cm Vertical travel 26.5 cm Table top locking Maximum patient capacity Electromagnetic 250 kg (551 lbs) Floatex+ Bucky Table 6-way floating top 6-way floating top 53.5 cm NA 18 cm NA 26.5 cm Electromagnetic 29 cm Electromagnetic 200 kg (440 lbs) 300 kg (660 lbs) Same Similar Functionality (Note 2) Similar Functionality (Note 2) Same as predicate 1 Same Similar Functionality (Note 1) Optional Model Type Longitudinal travel Transverse travel Table top locking Maximum patient capacity Floatex 4-way floating top 53.5 cm 20 cm Electromagnetic 250 kg (551 lbs) Floatex NA 4-way floating top NA 53.5 cm NA 20 cm NA Electromagnetic NA 200 kg (440 lbs) NA Same Same Same Same Similar Functionality (Note 1) Optional Model Type Longitudinal travel Transverse travel Vertical travel Table top locking Maximum patient capacity MobiT 6C Mobile with floating top 60 cm 20 cm 40 cm Electromagnetic 250 kg (551 lbs) MobiT 6C NA Mobile with floating top NA 60 cm NA 20 cm, NA 40 cm, NA Electromagnetic NA 200 kg (440 lbs) NA Same Same Same Same Same Similar Functionality (Note 1) Optional MobiT 4C MobiT 4C NA Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-9 Section 5-0 Allengers Medical Systems Limited Model Type Longitudinal travel Transverse travel Table top locking Maximum patient capacity Mobile with floating top 60 cm 20 cm Electromagnetic 250 kg (551 lbs) Mobile with floating top NA 60 cm NA 20 cm NA Electromagnetic NA 200 kg (440 lbs) NA Optional Model Mobit C Type Mobile Table top Fixed Maximum patient 200 kg (440 lbs) capacity 7. X-Ray Generator Kilowatt 65 kW rating 80 kW kV minimum (65/80) 40/40 kV kV maximum (65/80) 150/150 kV mA maximum @ 100kV 650/800 mA (65/80) mAs Range (65/80) 800/10000mAs APR programming Yes IR Remote Yes 8. X-Ray Tube Tube Type Varex Imaging G1092 Focal Spot sizes 0.6mm / 1.2mm Heat Units 1 MHU Target Angle Target Diameter Target Material 12° 108 mm RTM Mobit C Mobile Fixed 200 kg (440 lbs) 65 kW standard 80 kW optional 40/40 kV 150/150 kV 650/800 mA 800/1000mAs Yes No Varex Imaging G1092 0.6mm / 1.2mm 1 MHU 12° 108 mm RTM NA NA NA NA 65 kW standard 80 kW optional 40/40 kV 150/150 kV 650/800 mA NS Yes NA Siemens OPTITOP 0.6mm / 1.0mm 783 KHU 12° 100 mm RTM Same Same Same Same Similar Functionality (Note 1) Same Same Same Same Same Same Same Same Same as predicate 1 Same New Feature (Note 3) Same as predicate 1 Same as predicate 1 Same Same as predicate 1 Same Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-10 Section 5-0 Allengers Medical Systems Limited Optional Tube Focal Spot sizes Heat Units Target Angle Target Diameter Target Material Varex Imaging G292 0.6mm / 1.2mm 600 kHU 12° 102 mm RTM Varex Imaging G292 0.6mm / 1.2mm 600 kHU 12° 102 mm RTM Optional Tube Focal Spot sizes Heat Units Target Angle Target Diameter Target Material Varex Imaging A292 0.6mm / 1.2mm 400 kHU 12° 102 mm RTM Varex Imaging A292 0.6mm / 1.2mm 400 kHU 12° 102 mm RTM Optional Tube Focal Spot sizes Heat Units Target Angle Target Diameter Target Material Varex Imaging A192 0.6mm / 1.2mm 300 KHU 12° 102 mm RTM Varex Imaging A192 0.6mm / 1.2mm 300 KHU 12° 102 mm RTM Optional Tube Focal Spot sizes Heat Units Target Angle Varex Imaging RAD 14 0.6mm / 1.2 mm 300 kHU 12° Target Diameter 80 mm Target Material RTM 9. Beam Limiting Device Construction Multi-leaf CFR 211020.31 Compliant Automatic Yes Varex Imaging A192 0.6mm / 1.2mm 300 kHU 12° 102 mm RTM Multi-leaf Compliant Yes Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-11 Siemens OPTILIX 0.6mm / 1.0mm 600 kHU 16° 100 mm RTM Same as predicate 1 Same Same as predicate 1 Same as predicate 1 Same NA NA Same NA Same NA Same NA Same NA Same NA NA Same NA Same NA Same NA Same NA Same NA NA NA NA NA NA Multi-leaf Compliant Yes Same Same Same Similar Functionality (Note 4) Same Same Same Same Section 5-0 Allengers Medical Systems Limited 10. Solid State X-Ray Image Detector Model XRPAD 4343 F XRPAD 4343F FDA Cleared Yes, K142698 Yes, K142698 Panel Type Single substrate amorphous silicon active TFT/diode array Single substrate amorphous silicon active TFT/diode array Active area 432 mm X 432 mm 432 mm X 432 mm Pixel pitch 100 µm 100 m Pixel matrix 4318 X 4320 4318 X 4320 Trixell Pixium 4600 Yes, K093066 Amorphous Silicon 429 mm X 429 mm 143 m 3001 x 3001 Scintillator Limiting resolution Direct deposition CsI:Tl 5 Ip/mm Direct deposition CsI:Tl Cesium Iodide 5 lp/mm 3.6 lp/mm Same as predicate 1 Same as predicate 1 Same as predicate 1 Same as predicate 1 Same or similar with same imaging results Same as predicate 1 Optional Varex's PaxScan Model 4336R FDA Cleared Yes, K130318 Panel Type Amorphous Silicon with Charge Well PixelTM Technology Pixel Area(Active) Pixel pitch 353 mm 139 µm 424mm Pixel matrix Scintillator Limiting resolution 2560 X 3072 Direct Deposit CsI, Detached CsI, DRZ Plus 3.6 lp/mm Varex's PaxScan 4336R Yes, K130318 Amorphous Silicon with Charge Well PixelTM Technology 353mm X 424 mm 139 m 2560 X 3072 Direct Deposit CsI, Detached CsI, DRZ Plus 3.6 lp/mm Thales Pixium 3543 Yes, K093066 Pixium© CsI coupled to TFT matrix aSi technology Same as predicate 1 342 mm X 432 mm 144 m 2372 X 3000 Cesium Iodide Same as predicate 1 Same as predicate 1 Same as predicate 1 Same as predicate 1 3.6 lp/mm Same Model FDA Cleared Panel Type Active Area XRPAD 4336 Yes, K140551 Single substrate amorphous silicon active TFT/diode array 355 mm X 432 mm XRPAD 4336 Yes, K140551 Single substrate amorphous silicon active TFT/diode array 355 mm X 432 mm Pixel pitch 100 µm 100 m Pixel matrix 3556 X 4320 3556 X 4320 Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-12 Thales Pixium 3543 Yes, K093066 Pixium© CsI coupled to TFT matrix aSi technology Same as predicate 1 342 mm X 432 mm 144 m 2372 X 3000 Same as predicate 1 Same as predicate 1 Same as Section 5-0 Allengers Medical Systems Limited Scintillator Limiting resolution Direct deposition CsI:Tl 5 lp/mm Direct deposition CsI:Tl 5 lp/mm Cesium Iodide 3.6 lp/mm predicate 1 Same as predicate 1 Same as predicate 1 Optional Varex's PaxScan Model 4336W FDA Cleared Yes, K142049 Panel Type Amorphous Silicon Active Area Pixel pitch Pixel matrix Scintillator Limiting resolution 353 mm X 424 mm 139 µm 2560 X 3072 Direct Deposit CsI, DRZ + 3.6 lp/mm Varex's PaxScan 4336W Yes, K142049 Amorphous Silicon 353 mm X 424 mm 139 m 2560 X 3072 Direct Deposit CsI, DRZ + 3.6 lp/mm Thales Pixium 3543 Yes, K093066 Pixium© CsI coupled to TFT matrix aSi technology 342 mm X 432 mm 144 m 2372 X 3000 Cesium Iodide Same as predicate 1 Same as predicate 1 Same as predicate 1 Same as predicate 1 Same as predicate 1 3.6 lp/mm Same Optional Model FDA Cleared Panel Type Varex's PaxScan 4336W v4 Yes, K183541 Amorphous Silicon with TFT/PIN diode Technology Active Area 339 mm X 424 mm Pixel pitch 139 µm Pixel matrix 2476 X 3072 Scintillator Limiting resolution CsI, DRZ + 3.6 lp/mm Varex's PaxScan 4336W Yes, K142049 Amorphous Silicon 353 mm X 424 mm 139 m 2560 X 3072 CsI, DRZ + 3.6 lp/mm Thales Pixium 3543 Yes, K093066 Pixium© CsI coupled to TFT matrix aSi technology ) 342 mm X 432 mm 144 m 2372 X 3000 Cesium Iodide(CSI:Ti) Similar with same imaging results Similar Functionality (Note 5) Same as predicate 1 Similar Functionality (Note 5) Same as predicate 1 3.6 lp/mm Same Optional Model FDA Cleared Panel Type Thales Pixium 3543 DR-CS Yes, K182517 Pixium® CsI coupled to TFT matrix a-Si technology Active Area 350mm x430 mm Varex's PaxScan 4336W Yes, K142049 Amorphous Silicon 353 mm X 424 mm Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-13 Thales Pixium 3543 Yes, K093066 Pixium© CsI coupled to TFT matrix aSi technology 342 mm X 432 mm Same as predicate 2 Similar Functionality (Note 5) Section 5-0 Allengers Medical Systems Limited Pixel pitch Scintillator 160 µm 139 m Cesium Iodide(CSI:Ti) CsI, DRZ + 144 m Cesium Iodide Similar Functionality (Note 5) Same Optional Varex's PaxScan Model 4343R FDA Cleared Yes, K130318 Panel Type Amorphous Silicon with Charge Well PixelTMTechnology Active Area Pixel pitch Pixel matrix Scintillator Limiting resolution 424 mm X 424 mm 139 µm 3072 X 3072 Direct Deposit CsI, Detached CsI, DRZ Plus 3.6 lp/mm Varex's PaxScan 4343R Yes, K130318 Amorphous Silicon with Charge Well PixelTMTechnolog y 424 mm X 424 mm Trixell Pixium 4600 Yes, K093066 Amorphous Silicon 429 mm X 429 mm 139 m 143 m 3072 X 3072 Direct Deposit CsI, Detached CsI, DRZ Plus 3.6 lp/mm 3001 x 3001 Cesium Iodide 3.6 lp/mm Same as predicate 1 Same as predicate 1 Same as predicate 1 Same as predicate 1 Same as predicate 1 Same Optional Model VENU 1717X Panel Type Amorphous Silicon Varex Paxscan 4343R Amorphous Silicon with Charge Well PixelTMTechnolog y Trixell Pixium 4600 Amorphous Silicon Active Area 427 × 427 mm 424 mm X 424 mm 429 mm X 429 mm Pixel pitch Pixel matrix 139 µm 3072 × 3072 Scintillator Limiting resolution CsI 3.6 lp/mm 139 m 3072 X 3072 Direct Deposit CsI, Detached CsI, DRZ Plus 3.6 lp/mm 143 m 3001 x 3001 CsI 3.6 lp/mm Same as predicate 2 Essentially the Same imaging Area doesn't affect the patient safety or effectiveness. Same as predicate 1 Same as predicate 1 Same as predicate 2 Same Optional Model Varex's PaxScan 4343R v3 Varex's PaxScan 4343R Trixell Pixium 4600 Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-14 Section 5-0 Allengers Medical Systems Limited FDA Cleared Yes, K183541 Panel Type Amorphous Silicon with PIN Technology Active Area Pixel pitch Pixel matrix 424 mm X 424 mm 139 µm 3072 X 3072 Scintillator Limiting resolution CsI, DRZ+ 3.6 lp/mm Yes, K130318 Amorphous Silicon with Charge Well PixelTMTechnolog y 424 mm X 424 mm Yes, K093066 Amorphous Silicon 429 mm X 429 mm 139 m 143 m 3072 X 3072 3001 x 3001 Direct Deposit CsI, Detached CsI, DRZ Plus Cesium Iodide 3.6 lp/mm 3.6 lp/mm Same or similar with same imaging results Same as predicate 1 Same as predicate 1 Same as predicate 1 Same or Similar with same imaging results Same Optional Model FDA Cleared Panel Type Active Area Pixium RAD 4343 C-E Yes, K181279 Amorphous Silicon 423.3 x 425.4 Varex's PaxScan 4343R Yes, K130318 Amorphous Silicon with Charge Well PixelTMTechnolog y 424 mm X 424 mm Trixell Pixium 4600 Yes, K093066 Amorphous Silicon 429 mm X 429 mm Pixel pitch 148 µm 139 m 143 m Pixel matrix 2860 X 2874 Scintillator Cesium Iodide(CSI) 3072 X 3072 Direct Deposit CsI, Detached CsI, DRZ 3001 x 3001s Cesium Iodide Same as predicate 2 Similar Functionality (Note 5) Similar Functionality (Note 5) Similar Functionality (Note 5) Same as predicate 2 Optional Model Paxscan 4343CB FDA Cleared Yes, K190373 Panel Type Amorphous Silicon Active Area Pixel pitch 427mm x 427 mm 139 µm Varex's PaxScan 4343R Yes, K130318 Amorphous Silicon with Charge Well PixelTMTechnolog y Trixell Pixium 4600 Yes, K093066 Amorphous Silicon 427mm x 427 mm 429 mm X 429 mm 139 m 143 m Similar with Same imaging result Same as predicate 1 Same as Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-15 Section 5-0 Allengers Medical Systems Limited Pixel matrix Scintillator 3072 X 3072 Integral columnar Csl:Tl 3072 X 3072 Direct Deposit CsI, Detached CsI, DRZ 3001 x 3001 Cesium Iodide predicate 1 Same as predicate 1 Similar Functionality (Note 5) Optional Model Panel Type Varex's PaxScan 4336W v4 + Amorphous Silicon with TFT/PIN diode Technology Active Area 339 mm X 424 mm Pixel pitch 139 µm Pixel matrix 2476 X 3072 Scintillator Limiting resolution CsI, DRZ + 3.6 lp/mm Varex's PaxScan 4336W Amorphous Silicon with TFT/PIN diode Technology 353 mm X 424 mm 139 m 2560 X 3072 CsI, DRZ + 3.6 lp/mm Thales Pixium 3543 Pixium© CsI coupled to TFT matrix aSi technology Same as predicate 1 342 mm X 432 mm 144 m 2372 X 3000 Cesium Iodide Similar Functionality (Note 6) Same as predicate 1 Similar Functionality (Note 6) Same as predicate 1 3.6 lp/mm Same Optional Model MARS 1417V Panel Type a-Si (Amorphous Silicon) TFT Active Area 346 × 420 Pixel pitch 150 m Pixel matrix 2304 × 2800 Scintillator CsI Limiting Resolution 3.4 lp/mm Varex's PaxScan 4336W Amorphous Silicon 353 mm X 424 mm 139 m 2560 X 3072 CsI, DRZ + 3.6 lp/mm Thales Pixium 3543 Pixium© CsI coupled to TFT matrix aSi technology 342 mm X 432 mm 144 m 2372 X 3000 Cesium Iodide 3.6 lp/mm Same or Similar Functionality (Note 7) Same or Similar Functionality (Note 7) Same or Similar Functionality (Note 7) Same or Similar Functionality (Note 7) Same as predicate 2 Same or Similar Functionality (Note 7) Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-16 Section 5-0 Allengers Medical Systems Limited 11. Viewing Monitors Monitor 19 inch or more (minimum (Touch and Non Size) Touch) 12. Software Feature Model Synergy DR FDX DROC FDA Cleared -- K130883 Operating System Microsoft Windows 7/ Microsoft Window 10 Microsoft Windows7 / Microsoft Window 10 Network Ethernet/ Ethernet/ Wifi Wifi User Mouse, Keyboard , Mouse, Keyboard, Interaction/in Touch Touch put Monitor, Monitor, Multi-user Available Available Import/Export images Yes Yes Compute d Computed Acquisition device Radiogra Radiograp phy hy Digital Digital X- X-Ray Ray Detector Detector Image Interferences Detector depende nt Detector dependent Yes Yes Patient Patient ID/Name/ ID/Name/ Study Study Image Organization instance UID Patient instance UID Patient ID/Name/ ID/Name/ Study Study instance instance UID UID Image Search Yes Yes available Image Storage Yes Yes Database Yes Yes 19 inch Monitor DROC Yes, K130883 Microsoft Windows7 Ethernet/ Wifi Mouse, Keyboard, Touch Monitor, Available Yes Computed Radiography Digital X-Ray Detector Detector dependent Yes Patient ID/Name/Study instance UID Patient ID/Name/Study instance UID Yes Yes Yes Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-17 19 inch Monitor Similar Functionality ( Note 8 ) DelWorks DR System Yes, K140825 Microsoft Windows7 Similar Functionality (Note 9) Ethernet/ Wifi Mouse, Keyboard, Touch Monitor, Available Yes Same Same Same Same Same Computed Radiography Digital XRay Detector Same Detector dependent Same Yes Patient ID/Name/Study instance UID Patient ID/Name/Study instance UID Same Yes Same Yes Same Yes Same Section 5-0 Allengers Medical Systems Limited storage Database Software Image Viewing Image measuremen t Image Annotation Image Operation MSAccess Yes Yes Yes Yes MSAccess Yes Yes Yes Yes MS-Access Yes Yes Yes Yes Image Stitching Automati c Manual Manual Same Security DICOM 3.0 Compatibility Generator Control Generator Control Protocols Raw image Data Processing Post image data processing RIS code manager Yes(Prior ity by User) Yes Yes Generato r depende nt Yes Yes Yes Yes(Priorit Yes(Priority by y by User) User) Yes Yes Yes Yes Generator Generator dependent dependent Yes Yes Yes Yes Yes Yes Dual Energy Subtraction Yes No No 13. Biological Characteristics Table Top Material Carbon Composite Material Carbon Composite Material MS-Access Yes Same Same Yes Same Yes Yes Manual Yes(Priority by User) Same Same Similar Functionality (Note 9) Same Yes Same Yes Same Generator dependent Same Yes Yes Yes No Carbon Composite Material Same Same Same New Feature added (Note 10) Same Note Note 1 Note 2 Table 5 Justification for Differences Description Allengers DigiX FDX (Subject Device) is capable for carrying patient weight up to 250kg without raising any new risk related to patient safety or effectiveness. Patient table (Floatex ADV) modified with more travel which provide full patient coverage which doesn't affect the safety or effectiveness of device. Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-18 Section 5-0 Allengers Medical Systems Limited Note 3 Note 4 Note 5 Note 6 Note 7 Note 8 Note 9 Note 10 Optional Wireless IR Remote (make Tech switch) has same functionality as wired hand switch for Exposure. Wireless version doesn't raise any new safety or effectiveness issue. This feature is in EMC compliant and meet all necessary requirements pertaining to hand switch design as stated in 21 CFR Varex Rad 14 X-Ray tube is new X-Ray tube for existing device. However, the XRay tube used by subject device is already cleared by FDA under Stationary Digital radiography X-Ray device under 510(K) number K183541. Having same focal spot with different X-Ray tube loading and target diameter which provide essentially the same imaging results, which doesn't affect the safety or effectiveness. The subject device utilizes different X-Ray flat panel detectors; however, the flat panel detectors used by the subject device are already previously cleared by the FDA and does not raise the level of safety concern and affect any effectiveness. The relevant 510(k) approval number are K183541, K181279 & K182517 New Detector Paxscan 4336W v4 + added in subject device. The flat panel detector have all the technical specifications like Image area, Pixel Pitch, Active area, resolution same to detector Paxscan 4336 W v4 (Previously cleared under 510 (K) No. K183541) with light weight facility. The new additional Flat panel detector (Varex Paxscan 4336W v4+) doesn't affect the patient safety or effectiveness. The Subject Device utilized different Flat panel X-Ray detector (i.e. MARS 1417V) ,However the flat panel detector used by subject device is updated version of previously cleared FPD having 510(K) number K161730 with same imaging area , pixel pitch and same spatial resolution. The new additional Flat panel detector (MARS 1417V) doesn't affect the patient safety or effectiveness. Monitors with 19" or more in sizes (Touch and Non touch) are utilized in subject device with same imaging results which doesn't affect the patient safety or effectiveness. The subject device utilizes additional System software (SYNERGY DR FDX) with same and updated functionalities like automatic Image stitching, Dual Energy feature and update operating system. However Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The new software doesn't raise the level of safety concern and affect any effectiveness. Dual-energy subtraction chest radiography improves the radiologist's ability to detect and accurately diagnose a wide variety of chest lesions. The major advantage of this technique is that it makes calcification more conspicuous, an essential aid in characterizing pulmonary nodules. Thus this new feature doesn't affect the patient safety or effectiveness. 9. Reason for Submission Modification of cleared device Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-19 Section 5-0 Allengers Medical Systems Limited 10. Non-Clinical and Clinical Testing: Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. All devices subject to CDRH performance standards are certified to comply with the standard by their respective manufacturers. Risk Analysis was performed on the entire system. Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence. EMC/electrical safety was evaluated according to the IEC Standards. Allengers certify conformance to Voluntary Standards covering Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed. Safety Information: The Allengers Medical Systems Limited systems comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31. The Allengers Medical Systems Limited systems comply with the international safety standards: o IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+AM1:2012 o IEC 60601-1-2:2014 o IEC 60601-1-3:2008+A1:2013 o IEC 60601-2-54:2009+A1:2015 o EN ISO 14971:2012 o IEC 62366-1:2015 o IEC 62304:2006+AMD1:2015 Performance Testing: Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission. All functions met the design requirements and the image performance criteria satisfactorily. Clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system. 11. Substantial Equivalence Conclusion: The Allengers Medical Systems Limited systems do not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The operating environment and mechanical design is similar. Allengers Medical Systems Limited considers the DigiX FDX diagnostic X-Ray systems to be substantially equivalent with the predicate devices (K162529 & K081722) with respect to safety and effectiveness. Allengers Medical Systems Limited DigiX FDX 510(k) 5-0-20 Section 5-0