Wireless/Wired X-Ray Flat Panel Detectors
Device Facts
| Record ID | K223009 |
|---|---|
| Device Name | Wireless/Wired X-Ray Flat Panel Detectors |
| Applicant | Allengers Medical Systems Limited |
| Product Code | MQB · Radiology |
| Decision Date | Nov 27, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used. Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
Device Story
Device consists of wireless or wired X-ray flat panel detectors (FPDs) and Acquisition Workstation Software (AWS) Synergy DR FDX/Synergy DR. Detectors capture X-ray radiation, convert it to digital images, and transmit data to a PC/laptop/tablet. Used in clinical environments (e.g., wall bucky, table bucky, or free-cassette) by radiographers. Software provides user interface for patient registration, image acquisition, processing (zoom, pan, annotation, stitching, dual energy), storage, and DICOM-compliant export. Benefits include faster image transfer via compression, improved handling via rounded-edge design, and LED identification. Output allows radiologists to perform general radiographic exams. System synchronizes detector states with X-ray generators.
Clinical Evidence
Bench testing only. No clinical studies performed. Compliance with FDA-recognized consensus standards (e.g., IEC 60601-1, IEC 62304, ISO 10993, IEC 62220-1-1) and FDA guidance for solid-state X-ray imaging devices demonstrated safety and effectiveness. Image quality evaluation confirmed equivalence to predicate devices.
Technological Characteristics
Detectors use Cesium Iodide (CsI) or Gadolinium Oxy Sulfide (GOS) scintillators on glass or non-glass substrates. 16-bit A/D conversion. Connectivity via Gigabit Ethernet (wired) or IEEE 802.11 ac/a/g/n (wireless). Power via rechargeable lithium battery or wired connection. Dimensions range from 14x17 to 17x17 inches. Software is Class B (moderate level of concern) per IEC 62304. Biocompatibility per ISO 10993.
Indications for Use
Indicated for general projection radiographic applications for all body parts, excluding mammography, wherever conventional film/screen or CR systems are used.
Regulatory Classification
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
- Yushan X-Ray Flat Panel Detector with DROC (K201528)
- Yushan X-Ray Flat Panel Detector with DROC (K210988)
- Yushan X-Ray Flat Panel Detector with DROC (K220510)
Submission Summary (Full Text)
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Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2022
Allengers Medical Systems Limited % Sanjeev Marjara Additional Managing Director FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali, Punjab 140507 INDIA
### Re: K223009
Trade/Device Name: Wireless/Wired X-Ray Flat Panel Detectors Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MQB Dated: September 29, 2022 Received: September 29, 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
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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 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-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,
2022.11.27
20:51:59
-05'00'
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known) K223009
Device Name Wireless/ Wired X-Ray Flat Panel Detectors
Indications for Use (Describe)
Allengers Wireless / Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used
Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
Type of Use (Select one or both, as applicable)
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <span style="font-weight: bold;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |
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# 510(k) Summary
K223009
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
### I. SUBMITTER
| Company Name: | Allengers Medical Systems Limited |
|------------------|-----------------------------------------------------------------------------------------|
| Company Address: | FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi,<br>Distt Mohali-140507, India |
| Telephone No: | +91 1762-282600, +919872980168,<br>ra.fdaindia@allengers.net, rnd@allengers.net |
| Contact Person: | Sanjeev K. Marjara |
| Date Prepared: | Sep 26, 2022 |
### II. PROPOSED DEVICE
| Device (trade) name: | Wireless/ Wired X-Ray Flat Panel Detectors | |
|-------------------------|--------------------------------------------|----------|
| Model Name: | Wireless X-Ray Flat Panel Detectors | G4336RWC |
| | | G4336RWG |
| | | G4343RWC |
| | | G4343RWG |
| | | T4336RWC |
| | | T4336RWG |
| | Wired X-Ray Flat Panel Detectors | G4336RWC |
| | | G4336RWG |
| | | G4343RWC |
| | | G4343RWG |
| | | T4336RWC |
| | | T4336RWG |
| | | G4343RC |
| | | G4343RG |
| Regulation description: | Stationary x-ray system | |
| Review Panel: | Radiology | |
| Regulation Number : | 21 CFR 892.1680 | |
| Device Class: | Class II | |
| Product Code: | MOB | |
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## III. PREDICATE DEVICE
Substantial equivalence to the following predicate device is as follows:
| Device (trade) name: | Yushan X-Ray Flat Panel Detector with DROC |
|-------------------------|--------------------------------------------|
| 510(K) Number : | K201528 |
| Manufacturer : | InnoCare Optoelectronics Corp. |
| Decision Date : | October 11, 2020 |
| Regulation description: | Stationary x-ray system. |
| Review Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class : | Class II |
| Product Code: | MQB |
| Device (trade) name: | Yushan X-Ray Flat Panel Detector with DROC |
|-------------------------|--------------------------------------------|
| 510(K) Number: | K210988 |
| Manufacturer: | InnoCare Optoelectronics Corp. |
| Decision Date: | April 21, 2021 |
| Regulation description: | Stationary x-ray system. |
| Review Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | MQB |
| Device (trade) name: | Yushan X-Ray Flat Panel Detector with DROC |
|-------------------------|--------------------------------------------|
| 510(K) Number : | K220510 |
| Manufacturer : | InnoCare Optoelectronics Corp. |
| Decision Date : | April 14, 2022 |
| Regulation description: | Stationary x-ray system. |
| Review Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class : | Class II |
| Product Code: | MQB |
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### IV.DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is substantially equivalent product of its predicate device, Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, K220510. There are 8 models in this submission G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG are portable (wireless) and G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC (wired) Digital are non-portable detectors. The Wireless/ Wired X-Ray Flat Panel Detectors is designed to be used in any environment that would typically use a radiographic cassette for examinations. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for nongrid or free cassette exams. These medical devices have memory exposure mode, and extended image readout feature. Additionally, rounded-edge design for easy handling, image compression algorithm for faster image transfer, LED design for easy detector identification, extra protection against ingress of water.
This Device is currently indicated for general projection radiographic applications and the scintillator material is using cesium iodide (Csl) or gadolinium oxy sulfide (GOS).
The Wireless/ Wired X-Ray Flat Panel Detectors sensor can automatically collect x-ray from an x-ray source. It collects the x-ray and converts it into digital image and transfers it to Desktop computer / Laptop/ Tablet for image display. The x-ray generator (an integral part of a complete x-ray system), is not part of the submission. The sensor includes a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images, the personal computer is not part of this submission.
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR, runs on a Windows based Desktop computer/ Laptop/ Tablet as a user interface for radiologist to perform a general radiography exam. The function includes:
- 1. User Login
- 2. Display Connectivity status of hardware devices like detector
- 3. Patient entry (Manual, Emergency and Worklist)
- 4. Exam entry
- 5. Image processing
- 6. Search patient Data
- 7. Print DICOM Image
- 8. Exit
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The software level of concern has been determined to be moderate based on the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The cybersecurity risks have been addressed to assure that no new or increased cybersecurity risks were introduced as a part of device risk analysis. These risks are defined as sequence of events leading to a hazardous situation and the controls for these risks were treated and implemented as proposed in the risk analysis (e.g. requirements, verification). The device software is being used unchanged from the predicate system.
Software System: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR" is the user interface application of the Digital Radiography System. New patient register/ Work list retrieving, exposure control, image acquisition, image processing and data transmitting are all achieved at the Synergy DR FDX/ Synergy DR. The Synergy DR FDX/ Synergy DR also provide the control functions responsible for synchronizing the states of detector with the X-Ray generator. Synergy DR FDX/ Synergy DR Features:
- . Patient entry and Patient information storage
- Image Acquisition, processing and storage
- DICOM 3.0 MWL, MPPS, DICOM send, DICOM print
- . Post processing such as Zoom, PAN, Annotations etc.
- Advanced Features like automatic image stitching, Dual energy, auto positioning, dose display, automatic collimation etc.
### ୍ଧି Level of Concern:
According to IEC 62304:2006/Amd 1:2015 "Medical device software - Software life cycle processes", the software for this device was considered as a class B level of concern, since failures or latent flaws in the software could directly result in non-serious injury to the patient, operator, and/or bystander.
#### V. Indications for Use
Allengers Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR is used to acquire/ Process/ Display/ Store/ Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radiographic applications wherever a conventional film/screen or CR system is used.
Allengers Wireless/ Wired X-Ray Flat Panel Detector is not intended for mammography applications.
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### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR have the similar Indications for Use and substantially equivalent design, functional requirements as the models in K201528,
| Feature | Subject Device | Predicate Device | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | This submission | K201528 | K210988 | K220510 |
| 2. Product Code | | | | |
| Product<br>Classification<br>Code | MQB | MQB | MQB | MQB |
| 3. Product Classification | | | | |
| Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 4. Product name | | | | |
| Product name | Wireless/ Wired X-Ray Flat Panel<br>Detectors used with AWS (Acquisi-<br>tion Workstation Software) Syner-<br>gy DR FDX/ Synergy DR | Yushan X-Ray Flat Panel Detector with DROC | | |
| 5. Model name | | | | |
| Model name | G4336RWC | V14C | - | - |
| | G4336RWG | V14G | - | - |
| | G4343RWC | V17C | - | - |
| Feature | Subject Device | Predicate Device | | |
| | G4343RWG | V17G | - | |
| | G4343RG | V17Ge | - | |
| | T4336RWC | - | F14C | |
| | T4336RWG | - | F14G | |
| | G4343RC | - | V17Ce | |
| 6. Clinical | | | | |
| Indications for Use | Allengers Wireless (/ Wired X-Ray<br>Flat Panel Detectors used with<br>AWS (Acquisition Workstation<br>Software) Synergy DR FDX/ Syner-<br>gy DR is used to acquire/ Process/<br>Display/ Store/ Export radiograph-<br>ic images of all body parts using<br>Radiographic techniques. It is in-<br>tended for use in general radio-<br>graphic applications wherever a<br>conventional film/screen or CR<br>system is used.<br>Allengers Wireless/ Wired X-Ray | The Wireless(V14C, V14G,<br>V17C, V17G)/Wired(V14C,<br>V14G, V17C, V17G, V17Ge)<br>Yushan X-Ray Flat Panel De-<br>tector with DROC is intend-<br>ed to capture for display<br>radiographic images of hu-<br>man anatomy. It is intend-<br>ed for use in general pro-<br>jection radiographic appli-<br>cations wherever conven-<br>tional film/screen or CR sys-<br>tems may be used. The<br>Yushan X-Ray Flat Panel De- | The Wireless/Wired<br>Yushan X-Ray Flat Panel<br>Detector is intended to<br>capture for display radio-<br>graphic images of human<br>anatomy. It is intended<br>for use in general projec-<br>tion radiographic applica-<br>tions including pediatric<br>and neonatal exams<br>wherever conventional<br>film/screen or CR sys-<br>tems may be used. The<br>Yushan X-Ray Flat Panel | The Wired Yushan X-<br>Ray Flat Panel Detec-<br>tor is intended to cap-<br>ture for display radio-<br>graphic images of hu-<br>man anatomy. It is in-<br>tended for use in gen-<br>eral projection radio-<br>graphic applications<br>wherever convention-<br>al film/screen or CR<br>systems may be used.<br>The Yushan X-Ray Flat<br>Panel Detector is not<br>intended for mam- |
| | Flat Panel Detectors is not intend-<br>ed for mammography applica- | tector with DROC is not in-<br>tended for mammography, | Detector is not intended<br>for mammography, | mography, fluorosco- |
K210988, K220510. The comparisons of technological characteristics are listed in the following table.
Allengers Medical Systems Limited - 510(K)
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Allengers Medical Systems Limited - 510(K)
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| Feature | Subject Device | Predicate Device |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | tions. | fluoroscopy, tomography, and angiography applications. Yushan series provide either raw X ray image or corrected image for system integrator to do further image process. py, tomography, and angiography applications. The use of this product is not recommended for pregnant women and the risk of radioactivity must be evaluated by a physician. |
| Compliance standard | FDA Standards 21 CFR 892.1680 for stationary x-ray system<br>ISO 13485<br>ISO 14971<br>ANSI/AAMI ES60601-1<br>IEC 62220-1-1ISO 20417<br>IEC 60601-1-2<br>IEC 62304<br>IEC 60601-1-6<br>IEC 62366-1<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 15223-1<br>ANSI AAMI HE75 | FDA Standards 21 CFR 892.1680 for stationary x-ray system<br>European Medical Devices Directive (93/42/EEC)<br>EN ISO 13485<br>ISO 14971<br>ANSI/AAMI ES60601-1<br>CAN/CSA C22.2 No. 60601-1:14<br>IEC 60601-1-2<br>IEC 62304<br>IEC 60601-1-6<br>IEC 62366-1<br>ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 15223-1<br>ANSI AAMI HE75 |
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| Feature | Subject Device | Predicate Device | | | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|------------|
| Dimensions (inch.) | G4336RWG: (W)14X(H)17<br>G4336RWC: (W)14X(H)17<br>G4343RWG: (W)17X(H)17<br>G4343RWC: (W)17X(H)17<br>G4343RG: (W)17X(H)17<br>T4336RWG: (W)14X(H)17<br>T4336RWC: (W)14X(H)17<br>G4343RC: (W)17X(H)17 | V14G: (W)14X(H)17<br>V14C: (W)14X(H)17<br>V17G: (W)17X(H)17<br>V17C: (W)17X(H)17<br>V17Ge: (W)17X(H)17 | F14G: (W)14X(H)17<br>F14C: (W)14X(H)17 | V17Ce: (W)17X(H)17 | |
| Weight (Kg) | G4336RWG: 2.7<br>G4336RWC: 2.7<br>G4343RWG: 3.2<br>G4343RWC: 3.2<br>G4343RG: 3.5<br>T4336RWG: 2.3<br>T4336RWC: 2.5<br>G4343RC: 3.6 | V14G: @3<br>V14C: @3<br>V17G: @3<br>V17C: @3<br>V17Ge: @3 | F14G: @2<br>F14C: @2 | V17Ce: @3.5 | |
| Feature | Subject Device | | Predicate Device | | |
| Substrate | G4336RWG<br>G4336RWC<br>G4343RWG<br>G4343RWC<br>G4343RG<br>G4343RC | Glass<br>Non-Glass | Glass | Non-Glass<br>(polyethylene tereph-<br>thalate laminate) | Glass |
| | T4336RWG<br>T4336RWC | | | | |
| Scintillator | G4336RWG<br>G4343RWG<br>G4343RG<br>T4336RWG<br>G4336RWC | ૯૦૮ | V14G: GOS<br>V14C: Csl<br>V17G: GOS<br>V17C: Csl<br>V17Ge: GOS | F14G: GOS<br>F14C: Csl | V17Ce: Csl |
| | G4343RWC<br>T4336RWC<br>G4343RC | Cal | | | |
| A/D Conversion | 16 bit | | 16 bit | 16 bit | 16 bit |
| Feature | Subject Device | Predicate Device | | | |
| Pixels | G4336RWG: 2500 x 3052<br>G4336RWC: 2500 x 3052<br>G4343RWG: 3072 x 3072<br>G4343RWC: 3072 x 3072<br>G4343RG: 3072 x 3072<br>T4336RWG: 2500 x 3052<br>T4336RWC: 2500 x 3052<br>G4343RC: 3072 x 3072 | V14G: 2500 x 3052<br>V14C: 2500 x 3052<br>V17G: 3072 x 3072<br>V17C: 3072 x 3072<br>V17Ge: 3072 x 3072 | F14G: 2500 x 3052<br>F14C: 2500 x 3052 | V17Ce: 3072 x 3072 | |
| Interface | Wired: Gigabit Ethernet<br>Wireless: IEEE802.11 ac /a/g/n | Wired: Gigabit Ethernet<br>Wireless: IEEE802.11 ac<br>/a/g/n | Wired: Gigabit Ethernet<br>Wireless: IEEE802.11 ac<br>/a/g/n | Wired: Gigabit Ether-<br>net | |
| Power | Rechargeable Lithium Battery<br>*G4343RG, G4343RC Have no<br>Battery | Rechargeable Lithium Bat-<br>tery<br>* V17Ge has no Battery | Rechargeable Lithium<br>Battery | No Battery | |
| 8. Biological | | | | | |
| Biological safety | All material contact with patients<br>is in accordance with ISO 10993. | All material contact with<br>patients is in accordance<br>with ISO 10993. | All material contact with<br>patients is in accordance<br>with ISO 10993. | All material contact<br>with patients is in ac-<br>cordance with ISO<br>10993. | |
| 9. Others | | | | | |
| | Allengers Medical Systems Limited - 510(K)<br>5-0-10<br>Section 5-0 | | | | |
| Feature | Subject Device | Predicate Device | | | |
| Accessories | - Battery (Optional)*<br>- * G4343RG, G4343RC are not applicable<br>- Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord (Optional)<br>- Charger (Optional)<br>- Charger Adapter (Optional)<br>- AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR | - Battery (Optional)*<br>- * V17Ge is not applicable<br>- Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord | - Battery (Optional)<br>- Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord (Optional)<br>- Charger (Optional)<br>- Charger Adapter (Optional)<br>- DROC Dongle (Optional) | - Power supply (Adapter)<br>- SE cable (Back-up cable)<br>- Power Cord | |
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Allengers Medical Systems Limited - 510(K)
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#### VII. PERFORMANCE DATA
Non-clinical Performance Data: Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR confirms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 60601-1-6, ANSI AAMI IEC 62366-1 and ANSI/AAMI HE75. In addition, the FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices (issued on September 1, 2016) was followed to describe the detector characteristics; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) was followed to evaluate the level of concern as moderate; Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued on October 02, 2014) was also followed to consider issues related to cybersecurity in the design and development process of this device. Additionally, the risk analysis, necessary verification and validation activities were performed. Load-bearing characteristics and protection against ingress of water were tested and passed. The internal circuit design was demonstrated through EMC emission testing: IEC 60601-1-2 and the results were satisfactory. Biocompatibilities were demonstrated through ISO 10993 series to prove the using material safe and effective. Furthermore, the image quality evaluation confirmed that the image quality of the Wireless/ Wired X-Ray Flat Panel Detectors is substantially equivalent to that of the predicate device. Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
For 8 models in this submission, G4336RWC, G4336RWG, G4343RWC, G4343RWG, T4336RWC, T4336RWG, G4343RG, G4343RC, which are the subsequently equivalent model in K201528, K210988, K220510, only with slight change of product name, appearance and the labeling, therefore the performance data is the same and need no extra validation. Please refer to the following comparison table for models difference
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## Table 1
| Manufacturer | InnoCare Optoelectronics Corp. | Allengers Medical Systems Limited |
|--------------|-----------------------------------------------|--------------------------------------------|
| Product Name | Yushan X-Ray Flat Panel Detector<br>with DROC | Wireless/ Wired X-Ray Flat Panel Detectors |
| Model Name | FDA Cleared Device: K201528 | |
| | V14C | G4336RWC |
| | V14G | G4336RWG |
| | V17C | G4343RWC |
| | V17G | G4343RWG |
| | V17Ge | G4343RG |
| | FDA Cleared Device: K210988 | |
| | F14C | T4336RWC |
| | F14G | T4336RWG |
| | FDA Cleared Device: K220510 | |
| | V17Ce | G4343RC |
### VIII. Description of Non Clinical & Clinical testing
Non Clinical performance testing has been performed on the Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR system and it demonstrates compliance with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| Standard/<br>Guidance | Standard Title | Status | FDA Con-<br>sensus<br>Number | Self- De-<br>clared | Comments/<br>Deviations |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|---------------------|--------------------------------|
| Standard | AAMI / ANSI ES60601-<br>1:2005/(R) 2012 And A1:<br>2012, C1:2009/(R) 2012 And<br>A2:2010/ (R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, | Met all<br>requirements | 19-4 | Yes | No deviations<br>from standard |
| | Mod). (General II (ES/EMC)) | | | | |
| Standard | IEC 60601-1-2: 2014_Medi-<br>cal Electrical Equipment -<br>Part 1-2: General Require-<br>ments For Basic Safety And<br>Essential Performance - Col-<br>lateral Standard: Electro-<br>magnetic Compatibility - Re-<br>quirements And Tests | Met all<br>require-<br>ments | 19-8 | Yes | No deviations<br>from standard |
| Standard | IEC 62304 Edition 1.1 2015-<br>06 CONSOLIDATED VERSION<br>Medical device software -<br>Software life cycle processes | Met all<br>require-<br>ments | 13-79 | Yes | No deviations<br>from standard |
| Standard | IEC 60601-1-6 Edition 3.1<br>2013-10, Medical Electrical<br>Equipment - Part 1-6: Gen-<br>eral Requirements For Basic<br>Safety And Essential Perfor-<br>mance - Collateral Standard:<br>Usability. (General I<br>(QS/RM)) | Met all<br>require-<br>ments | 5-89 | Yes | No deviations<br>from standard |
| Standard | ANSI AAMI IEC 62366-1 Edi-<br>tion 1.0 2015-02 Medical de-<br>vices - Part 1: Application of<br>usability engineering to med-<br>ical devices [Including COR-<br>RIGENDUM 1 (2016)] | Met all<br>require-<br>ments | 5-114 | Yes | No deviations<br>from standard |
| Standard | ISO 10993-1 Fifth edition<br>2018-08 Biological evalua- | Met all<br>require-<br>ments | 2-258 | Yes | No deviations<br>from standard |
| | tion of medical devices - Part<br>1: Evaluation and testing<br>within a risk management<br>process | ments | | | |
| Standard | ISO 10993-10: Fourth edition<br>2021-11 Biological evalua-<br>tion of medical devices --<br>Part 10: Tests for irritation<br>and skin sensitization | Met all<br>require-<br>ments |…
