← Product Code [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR) · K223060 # DigiX FDX (K223060) _Allengers Medical Systems Limited · KPR · Oct 26, 2022 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K223060 ## Device Facts - **Applicant:** Allengers Medical Systems Limited - **Product Code:** [KPR](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR.md) - **Decision Date:** Oct 26, 2022 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1680 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Pediatric ## Intended 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. ## Device Story DigiX FDX is a stationary X-ray system for general radiographic imaging. It consists of a ceiling-mounted tube suspension, vertical Bucky stand, patient table, X-ray generator, beam-limiting device, and digital X-ray detector (fixed, wired, or wireless). Operated by clinicians in hospitals/clinics, the system converts X-ray radiation into electronic signals to generate diagnostic images. The Synergy DR FDX software manages image acquisition, processing, storage, and DICOM 3.0-compliant communication. The system supports manual/automatic image stitching and dual-energy subtraction. Output is displayed on monitors for physician review to aid clinical decision-making. Benefits include improved workflow and diagnostic visualization for various patient populations. ## Clinical Evidence No clinical data provided. Substantial equivalence is supported by bench testing, including verification and validation of system functions, image performance evaluation, and safety testing against recognized consensus standards (IEC 60601 series, ISO 14971). ## Technological Characteristics Stationary X-ray system; 400 VAC power; carbon composite table top. Components: X-ray generator (65/80kW), multi-leaf beam-limiting device, and various solid-state digital detectors (fixed/wired/wireless). Connectivity: Ethernet/Wi-Fi, DICOM 3.0. Software: Synergy DR FDX (Windows 7/10). Compliance: 21 CFR 1020.30/1020.31, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-54. ## Regulatory Identification A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. ## Special Controls *Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. ## Predicate Devices - DigiX FDX ([K192541](/device/K192541.md)) ## Reference Devices - Ysio ([K081722](/device/K081722.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ October 26, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali, Punjab 140507 INDIA #### Re: K223060 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 20, 2022 Received: September 30, 2022 #### Dear 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 531-542 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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-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, Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K223060 Device Name DigiX FDX 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ☑ 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." {3}------------------------------------------------ ### 510(k) SUMMARY K223060 This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92. ### 1. Contact Person and Address | Company Name: | Allengers Medical Systems Limited | |------------------|-----------------------------------------------------------------------------------------| | Company Address: | FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi,
Distt Mohali-140507, India | | Telephone No: | +91 1762-282600
+919872980168
rnd@allengers.net | | Contact Person: | Sanjeev K. Marjara | | Date Prepared: | 20.09.2022 | ### 2. Proposed Device: | Device (trade) name: | DigiX FDX | |-----------------------|------------------------------| | Common/usual Name: | Digital X-Ray imaging system | | Classification Name : | Stationary X-Ray system | | Classification Panel: | Radiology | | Regulation Number : | 21 CFR 892.1680 | | Device Class: | Class II | | Product Code: | KPR | | 510(K) Submission: | Special | ### 3. Predicate Device: | Device (trade) name: | DigiX FDX | |-----------------------|------------------------------| | Common/usual Name: | Digital X-Ray imaging system | | Classification Name: | Stationary X-Ray system | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | | Product Code: | KPR | | 510(K) Number: | K192541 | | Clearance Date: | October 16, 2019 | ### 4. Reference devices: | Device (trade) name: | Ysio | |-----------------------|------------------------------| | Common/usual Name: | Digital X-Ray imaging system | | Classification Name: | Stationary X-Ray system | | Classification Panel: | Radiology | | Regulation Number : | 21 CFR 892.1680 | | Device Class : | Class II | | Product Code: | KPR | | 510(K) Number : | K081722 | | Clearance Date : | August 25, 2008 | {4}------------------------------------------------ Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have been previously cleared by FDA or tested and evaluated per guidance for submission of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state detectors used with device. | Solid State X-Ray Image Detectors | 510(K) Numbers | |--------------------------------------------|----------------| | Fixed | | | Varex PaxScan 4343R v3- Fixed | K172951 | | Varex Paxscan 4343DXV - Fixed | K220311 | | Varex Paxscan 4343RC - Fixed | K172951 | | IRAY VENU 1717X – Fixed | K221714 | | *IRAY Mercu 1717V3 - Fixed | -- | | Allengers FP 4343R- Fixed | -- | | *Allengers FP 4343RF- Fixed | -- | | Varex (Perkin Elmer ) XRPAD 4343F- Fixed | K142698 | | Wired/ Wireless | | | InnoCare Yushan V17Ge (Wired) | K201528 | | InnoCare Yushan V17Ce (Wired) | K220510 | | Allengers G4343RG (Wired) | -- | | Allengers G4343RC (Wired) | -- | | InnoCare Yushan F14C (Wired/Wireless) | K210988 | | InnoCare Yushan F14G (Wired/Wireless) | K210988 | | InnoCare Yushan V14C (Wired/Wireless) | K201528 | | InnoCare Yushan V14G (Wired/Wireless) | K201528 | | InnoCare Yushan V17C (Wired/Wireless) | K201528 | | InnoCare Yushan V17G (Wired/Wireless) | K201528 | | Allengers G4336RWC (Wired/Wireless) | -- | | Allengers G4336RWG (Wired/Wireless) | -- | | Allengers G4343RWC (Wired/Wireless) | -- | | Allengers G4343RWG (Wired/Wireless) | -- | | Allengers T4336RWC (Wired/Wireless) | -- | | Allengers T4336RWG (Wired/Wireless) | -- | | Varex (Perkin Elmer) XRPAD 4336 – Wireless | K140551 | | Varex PaxScan 4336W v4 + - Wireless | K192541 | | Varex PaxScan 4343W – Wireless | K211423 | | Varex Lumen 2530W – Wireless | -- | | Varex Lumen 4336W – Wireless | -- | | Varex Lumen 4343W – Wireless | -- | | Thales Pixium 3543 DR-CS (Wireless) | K182517 | | IRAY MARS 1417V (Wireless) | K192541 | | IRAY MARS 1417X (Wireless) | K210316 | | IRAY MARS 1717V (Wireless) | K201043 | | *IRAY MARS 1717Vn (Wireless) | K201043 | | IRAY MARS 1717X (Wireless) | K210314 | | IRAY LUNA 1012X (Wireless) | K221345 | | Allengers FP 4336RW (Wireless) | -- | | Allengers FP 4343RW (Wireless) | -- | | Allengers FP 4336RW-HR (Wireless) | -- | | Allengers FP 4343RW-HR (Wireless) | -- | | *Allengers FP 4343RW-DE (Wireless) | -- | | Allengers FP 2430RW-FLX (Wireless) | -- | ### Table 1 List of Solid State X-Ray Image Detectors {5}------------------------------------------------ Note: The Solid State X-Ray Image Detectors (Digital detectors) marked with "* can be used with Dual Energy Subtraction feature. ### 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. | Component | Manufacture | Model | |-----------------------------------------------|----------------------|--------------------| | Ceiling Mounted X-Ray Tube Suspension | Allengers | CSA FDX | | Vertical Bucky Stand | Allengers | VBS ADV | | Vertical Bucky Stand | Allengers | VBS M XL | | Patient Table - Fixed | Allengers | Floatex ADV | | Patient Table - Fixed | Allengers | Floatex | | Patient Table - Fixed | Allengers | Floatex XL | | Patient Table - Mobile | Allengers | MobiT 6C | | Patient Table - Mobile | Allengers | MobiT 4C | | Patient Table - Mobile | Allengers | MobiT C | | X-Ray Generator | Allengers | XGEN-80R | | X-Ray Generator | Allengers | XGEN-65R | | X-Ray Tube | Varex | A192 | | X-Ray Tube | Varex | A292 | | X-Ray Tube | Varex | G292 | | X-Ray Tube | Varex | G1092 | | X-Ray Tube | Varex | RAD14 | | Beam Limiting Device | Ralco | R225 ACS | | Solid State X-Ray Image Detector - Fixed | Varex | PaxScan 4343R v3 | | Solid State X-Ray Image Detector - Fixed | Varex | Paxscan 4343DXV | | Solid State X-Ray Image Detector – Fixed | Varex | Paxscan 4343RC | | Solid State X-Ray Image Detector – Fixed | IRAY | VENU 1717X | | Solid State X-Ray Image Detector – Fixed | IRAY | Mercu 1717V3 | | Solid State X-Ray Image Detector – Fixed | Allengers | FP 4343R | | Solid State X-Ray Image Detector – Fixed | Allengers | FP 4343RF | | Solid State X-Ray Image Detector -Wired | Varex (Perkin Elmer) | XRPAD 4343F | | Solid State X-Ray Image Detector – Wired | InnoCare | Yushan V17Ge | | Solid State X-Ray Image Detector – Wired | InnoCare | Yushan V17Ce | | Solid State X-Ray Image Detector – Wired | Allengers | G4343RG | | Solid State X-Ray Image Detector – Wired | Allengers | G4343RC | | Solid State X-Ray Image Detector – WiFi | Varex (Perkin Elmer) | XRPAD 4336 | | Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4336W V4 + | | Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4343W | | Solid State X-Ray Image Detector – WiFi | Varex | Lumen 2530W | | Solid State X-Ray Image Detector – WiFi | Varex | Lumen 4336W | | Solid State X-Ray Image Detector – WiFi | Varex | Lumen 4343W | | Solid State X-Ray Image Detector – WiFi | Thales | Pixium 3543DR-CS | | Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V14C | | Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V14G | | Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan F14C | | Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan F14G | | Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V17C | | Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V17G | | Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1417V | | Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1417X | | Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717V | | Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717Vn | | Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717X | | Solid State X-Ray Image Detector – WiFi | IRAY | LUNA 1012X | | Solid State X-Ray Image Detector – WiFi | Allengers | FP 4336RW | | Solid State X-Ray Image Detector – WiFi | Allengers | FP 4336RW-HR | | Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW | | Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW-HR | | Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW-DE | | Solid State X-Ray Image Detector – WiFi | Allengers | FP 2430RW-FLX | | Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4336RWC | | Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4336RWG | | Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4343RWC | | Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4343RWG | | Solid State X-Ray Image Detector – WiFi/Wired | Allengers | T4336RWC | | Solid State X-Ray Image Detector – WiFi/Wired | Allengers | T4336RWG | | Image processing Software | e-Com | DROC | | Image Processing Software | Allengers | Synergy DR FDX | ### Table 2 Combination Details {6}------------------------------------------------ {7}------------------------------------------------ ### 6. 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 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. #### 7. Technological Characteristics Comparison to Predicate & Reference Devices: The Subject device DigiX FDX design is based on the Allenger's DigiX FDX (K192541) 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 (K192541). The changes to the predicate DigiX FDX (K192541) include: ### System Software Synergy DR FDX - Graphical user interface (GUI): GUI of system software updated in order to ● improve the look and feel of user interface for better visibility & faster workflow. - Updated to support all hardware modifications. Verification and Validation testing . concluded no impact on safety and effectiveness. #### Component Change - 25x30cm Wireless Detectors are added (Listed below), ● - Lumen 2530W manufactured by Varex Imaging ● - Luna 1012X manufactured by IRAY technology ● - FP 2430RW-FLX manufactured by Allengers {8}------------------------------------------------ - 43x36cm Wired/Wireless Detectors are added (Listed below), ● - Lumen 4336W manufactured by Varex Imaging ● - MARS 1417X manufactured by IRAY technology. . - Yushan V14C manufactured by InnoCare Optoelectronics. ● - Yushan V14G manufactured by InnoCare Optoelectronics. ● - Yushan F14C manufactured by InnoCare Optoelectronics. ● - Yushan F14G manufactured by InnoCare Optoelectronics. ● - FP 4336RW manufactured by Allengers - FP 4336RW-HR manufactured by Allengers - T4336RWC manufactured by Allengers ● - T4336RWG manufactured by Allengers ● - G4336RWC manufactured by Allengers ● - G4336RWG manufactured by Allengers ● - 43x43cm Wired/Wireless Detectors are added (Listed below), ● - Paxscan 4343W manufactured by Varex imaging ● - Lumen 4343W manufactured by Varex Imaging - MARS 1717V manufactured by IRAY technology. ● - MARS 1717Vn manufactured by IRAY technology. ● - MARS 1717X manufactured by IRAY technology. - Yushan V17C manufactured by InnoCare Optoelectronics. ● - Yushan V17G manufactured by InnoCare Optoelectronics. ● - Yushan V17Ge manufactured by InnoCare Optoelectronics. - Yushan V17Ce manufactured by InnoCare Optoelectronics. ● - FP 4343RW manufactured by Allengers ● - . FP 4343RW-HR manufactured by Allengers - FP 4343W-DE manufactured by Allengers ● - G4343RWC manufactured by Allengers ● - G4343RWG manufactured by Allengers ● - G4343RG manufactured by Allengers . - . G4343RC manufactured by Allengers - 43x43cm Fixed Detectors are added (Listed below), . - Paxscan 4343RC manufactured by Varex imaging ● - Mercu 1717V3 manufactured by IRAY technology. - . FP 4343R manufactured by Allengers - FP 4343RF manufactured by Allengers ● ### 8. Software Feature Synergy DR FDX imaging software manufactured by Allengers Medical systems Limited is a Digital Imaging System (DIS) provides useful functions to manage X-Ray images obtained from digital radiography system. The software feature set and functions is essentially the same as the device, with the system complying with DICOM 3.0 specifications .Refer to 'Image processing and storage' in Section 13 (Page 5-0-10 to page 5-0-12) under table 4 of this document for a list of top level functions. {9}------------------------------------------------ #### 9. Substantial Equivalence: The DigiX FDX radiographic X-Ray system is substantially equivalent to the commercially available predicate Allenger's DigiX FDX Cleared October 16, 2019 with K192541 and Ysio (K081722). 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. | Predicate Device(s) Name
and Manufacture | 510(K)
Number | Clearance Date | Comparable
Properties | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------|----------------------------------------------------| | Predicate Device
DigiX FDX
Product Code: KPR
Address: Allengers Medical
Systems Ltd. Bhankharpur,
Mubarakpur
Road, Derabassi, Distt
Mohali-140507 India | K192541 | 10/16/2019 | Technical Design Mechanical Design System Software | | Reference Device: Ysio
Product Code: KPR
Address: Siemens Medical
Solutions USA, Inc,
51 valley stream, Parkway E-
50, Malvern PA, 19335-1406 | K081722 | 8/25/2008 | Technical Design Mechanical Design System Software | Table 3 Predicate Device Comparable Properties {10}------------------------------------------------ | Feature | DigiX FDX
(Subject Device) | DigiX FDX
(Predicate Device) | Siemens Ysio
(Reference Device) | Justification for
differences | | | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------| | 1. 510(k) | This submission | K192541 | K081722 | | | | | 2. Product Code | | | | | | | | Product
Classification
Code | KPR | KPR | KPR | Same | | | | 3. Product Classification | | | | | | | | Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | | | | 4. Indication 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. | 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. | 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
with conventional
film/screen or
Computed
Radiography (CR)
Cassettes | Essentially the
same
Note: There are
no
differences
between
the subject device
and the predicate
with respect to
indication and
intended use. | | | | Feature | DigiX FDX
(Subject Device) | DigiX FDX
(Predicate Device) | Siemens Ysio
(Reference Device) | Justification for
differences | | | | 5. X-Ray Generator | | | | | | | | Power | XGEN-80R : 80KW | XGEN-80R : 80KW | 80KW Standard | | | | | Rating (KW) | XGEN-65R : 65KW | XGEN-65R : 65KW | 65KW Optional | Same | | | | kV minimum
(65/80) | 40/40 kV | 40/40 kV | 40/40 kV | Same | | | | kV maximum
(65/80) | 150/150 kV | 150/150 kV | 150/150 kV | Same | | | | mA
maximum @
100kV
(65/80) | 650/800 mA | 650/800 mA | 650/800 mA | Same | | | | mAs Range
(65/80) | 800/1000mAs | 800/1000mAs | NS | Same as predicate
device | | | | APR
programming | Yes… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K223060](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KPR/K223060) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com