(135 days)
No
The description mentions image processing but does not include any explicit mention of AI, Machine Learning, or Deep Neural Networks, nor does it describe any functionality typical of an AI model beyond basic image processing.
No
The device is used to acquire, process, display, store, and export radiographic images for diagnostic purposes, not to treat a medical condition.
No
This device is an X-ray flat panel detector that acquires radiographic images. While these images are used for diagnosis, the device itself is an imaging tool and does not interpret or diagnose conditions from the images. It's a component of a larger system used for diagnosis, but not a diagnostic device in its own right.
No
The device is not a software-only medical device because the core device described is a physical Wireless/Wired X-Ray Flat Panel Detector, which is hardware. While it includes associated software (AWS), the primary medical device function of acquiring X-ray images is performed by the physical detector.
No.
This device is an X-ray Flat Panel Detector, which is an imaging device used to acquire radiographic images of the human body. IVD devices are used to examine specimens derived from the human body (e.g., blood, urine) for diagnostic purposes, not to directly image internal structures.
N/A
Intended Use / 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/screener CR system is used.
Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.
Product codes
MQB
Device Description
Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR" is Subject Device with equivalent product of its predicate device with K223009 and Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, and K220510. There are 4 models in this submission G4336RWC, G4343RWC, T4336RWC, are portable (wireless) and G4336RWC, G4343RWC, T4336RWC, G4343RC are non-portable (wired) Digital detectors.
The Wireless/ Wired X-Ray Flat Panel Detectors are 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 non-grid 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 (CsI). 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 Accessory: "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:
- User Login
- Display Connectivity status of hardware devices like detector
- Patient entry (Manual, Emergency and Worklist)
- Exam entry
- Image processing
- Search patient Data
- Print DICOM Image
- Exit
The software documentation level has been determined to be "Basic" based on the "Guidance for the Content of Premarket Submissions for Device Software Functions".
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, and Annotations etc.
• Advanced Features like automatic image stitching, dual energy, auto positioning, dose display, automatic collimation etc.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
all body parts
Indicated Patient Age Range
Not Found (Reference device K201528, K210988, K220510 mentions "pediatric and neonatal exams")
Intended User / Care Setting
radiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing included functional testing i.e. Bench testing to evaluate the impact of different scintillator thicknesses on the image quality of FPDs. The non-clinical testing identified in the guidance for submission of 510(k)s for Solid state X-Ray imaging devices (SSXI) was performed and demonstrated adequate system performance and Imaging performance.
Non-clinical Performance Data: Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "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 Device Software Functions (issued on June 14, 2023) was followed to evaluate the level of documentation as "Basic". 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. 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.
There are 4 models in this submission, G4336RWC, G4343RWC, T4336RWC, and G4343RC which are equivalent to the Predicate device. There is no change in accordance with Model Name, intended use, appearance & software. Only change in DQE, MTF, Sensitivity and thickness of Scintillator and due to this change there are no new safety and effectiveness issues being raised.
In conclusion, the modification of the 600μm CsI scintillator has been thoroughly evaluated and is deemed acceptable, as it does not significantly impact the safety, effectiveness, or intended use of the cleared model. This modification maintains compliance with fundamental scientific technology and the identified risk of electrical hazards was successfully mitigated.
Experimental results also confirm that the 600μm CsI provides superior noise performance and smoother image quality compared to the 400μm CsI, without clinically significant degradation of details or edges. Hence, this modification maintains diagnostic image quality as compared to the predicate. The data supports the substantial equivalence of the subject device to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE (Detective Quantum Efficiency)
- CsI: at 0.5 lp/mm, 0.85 (Max.).
- CsI: at 1 lp/mm, 0.69 (Max.).
- CsI: at 2 lp/mm, 0.54 (Max.).
MTF (Modulation Transfer Function)
- CsI: at 0.5 lp/mm, 0.95 (Max.)
- CsI: at 1 lp/mm, 0.70 (Max.).
- CsI: at 2 lp/mm, 0.41 (Max.).
Thickness of Scintillator
• Thickness of Scintillator: 600um
Sensitivity
• Sensitivity: ≥ 801 LSB/uGy (Max.)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 18, 2025
Allengers Medical Systems Limited
℅ Sanjeev K. Marjara
Managing Director
FDA Hall, Unit-2,
Bhankarpur, Mubarakpur Road, Derabassi, Distt Mohali
SAS Nagar Mohali, PUNJAB 140507
INDIA
Re: K243734
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: November 27, 2024
Received: March 21, 2025
Dear Sanjeev K. 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 (the 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 available 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.
Page 2
K243734 - Sanjeev K. Marjara
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-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/medical-devices/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-regulatory-
Page 3
K243734 - Sanjeev K. Marjara
Page 3
assistance/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,
for
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
Page 4
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Submission Number (if known)
K243734
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/screener CR system is used.
Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.
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."
Page 5
Allengers Medical Systems Limited
Allengers Medical Systems Limited - 510(K) 1
510(k) Summary
This summary of 510(k) are 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, Distt Mohali, SAS Nagar Mohali, Punjab, 140507, India |
| Telephone No: | +91-1762-272600, +919872980168 |
| ra.fdaindia@allengers.net, rnd@allengers.net | |
| Contact Person: | Sanjeev K. Marjara |
| Prepared Date: | 27 November 2024 |
| 510K Number | K243734 |
II. PROPOSED DEVICE
| 510(k) Submission: | Special Type |
|---|---|
| Device (Trade) Name: | Wireless/ Wired X-Ray Flat Panel Detectors |
| Model Number: | Wireless: G4336RWC, G4343RWC, T4336RWC, Wired : G4336RWC, G4343RWC, T4336RWC, G4343RC |
| Regulation Description: | Stationary x-ray system. |
| Review Panel | Radiology |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
III. Predicate Device
| Device (Trade) Name: | Wireless/ Wired X-Ray Flat Panel Detectors(K223009) |
|---|---|
| Model Number: | Wireless: G4336RWC, G4343RWC, T4336RWC, Wired : G4336RWC, G4343RWC, T4336RWC, G4343RC |
| Regulation Description: | Stationary x-ray system. |
| Review Panel | Radiology |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
IV. Reference Device
| Reference Device | Yushan X-Ray Flat Panel Detector with DROC (K201528, K210988, K220510) |
|---|---|
| Manufactured by: | InnoCare Optoelectronics Corp |
| Regulation description: | Stationary x-ray system. |
| Review Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
Page 6
Allengers Medical Systems Limited - 510(K) 2
V. DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR" is Subject Device with equivalent product of its predicate device with K223009 and Yushan X-Ray Flat Panel Detector with DROC, K201528, K210988, and K220510. There are 4 models in this submission G4336RWC, G4343RWC, T4336RWC, are portable (wireless) and G4336RWC, G4343RWC, T4336RWC, G4343RC are non-portable (wired) Digital detectors.
The Wireless/ Wired X-Ray Flat Panel Detectors are 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 non-grid 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 (CsI). 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 Accessory: "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:
- User Login
- Display Connectivity status of hardware devices like detector
- Patient entry (Manual, Emergency and Worklist)
- Exam entry
- Image processing
- Search patient Data
- Print DICOM Image
- Exit
The software documentation level has been determined to be "Basic" based on the "Guidance for the Content of Premarket Submissions for Device Software Functions".
Page 7
Allengers Medical Systems Limited - 510(K) 3
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, and Annotations etc.
• Advanced Features like automatic image stitching, dual energy, auto positioning, dose display, automatic collimation etc.
VI. 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/screener CR system is used.
Allengers Wireless/Wired X-ray Flat Panel Detectors are not intended for mammography applications.
VII. Technological Characteristics Comparison to Predicate & Reference Devices:
Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR" is Subject Device and only made changes in the DQE, MTF and thickness in the Subject Device Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR of Allengers Medical Systems Limited. The AWS software is unmodified compared to the predicate device.
This 510(k) submission describes some modifications to the Subject Device Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR. Change in the thickness of Scintillator trigger differences in image quality metrics (DQE, MTF) in the Subject Device as compared to the Predicate Device (K223009). However, these changes do not affect the intended use of device and its performance. However, modifications into the DQE, MTF, and Scintillator thickness maintain the device's diagnostic image quality as compared to the predicate device.
The details of changes to the Subject Device include:
DQE (Detective Quantum Efficiency)
- CsI: at 0.5 lp/mm, 0.85 (Max.).
- CsI: at 1 lp/mm, 0.69 (Max.).
- CsI: at 2 lp/mm, 0.54 (Max.).
Page 8
Allengers Medical Systems Limited - 510(K) 4
MTF (Modulation Transfer Function)
- CsI: at 0.5 lp/mm, 0.95 (Max.)
- CsI: at 1 lp/mm, 0.70 (Max.).
- CsI: at 2 lp/mm, 0.41 (Max.).
Thickness of Scintillator
• Thickness of Scintillator: 600um
Sensitivity
• Sensitivity: ≥ 801 LSB/uGy (Max.)
Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR" are Subject Device equivalent with its predicate device "Wireless/ Wired X-Ray Flat Panel Detectors with AWS (Acquisition Workstation Software) Synergy DR FDX/Synergy DR with K223009" and there is no change in accordance with Model Name, indented use, appearance & software. Only change in DQE, MTF, Sensitivity and thickness of Scintillator and due to this change there are no new safety and effectiveness issues being raised.
The comparisons of technological characteristics are listed in the following table below.
Page 9
Allengers Medical Systems Limited - 510(K) 5
| Feature | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| 510(k) | This submission | K223009 | K201528 K210988 K220510 |
| Product Code | |||
| Product Classification Code | MQB | MQB | MQB |
| Product Classification | |||
| Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 |
| Product name | |||
| Product name | Wireless/ Wired X-Ray Flat Panel Detectors | Wireless/ Wired X-Ray Flat Panel Detectors | Yushan X-Ray Flat Panel Detector with DROC |
| Model Name | |||
| Model name | G4336RWC | G4336RWC | V14C |
| G4343RWC | G4343RWC | V17C | |
| T4336RWC | T4336RWC | F14C | |
| G4343RC | G4343RC | V17Ce |
Page 10
Allengers Medical Systems Limited - 510(K) 6
| Feature | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Clinical | |||
| 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/screener CR system is used. Allengers Wireless/ Wired X-Ray Flat Panel Detectors are not intended for mammography applications. | Allengers Wireless/ Wired X-Ray Flat Panel Detectors used with AWS (Acquisition Workstation Software) Synergy DR FDX/Synergy DR is used to aquire/Process/Display/Store/Export radiographic images of all body parts using Radiographic techniques. It is intended for use in general radio-graphic applications wherever a conventional film/screener CR system issued. Allengers Wireless/ Wired X-Ray Flat Panel Detectors are not intended for mammography applications. | The Wireless/Wired Yushan X-Ray Flat Panel Detector is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The Yushan X-Ray Flat Panel Detector is not intended for mammography, fluoroscopy, tomography, and angiography applications. Yushan series provide either raw X ray image or corrected image for system integrator to do further image process. |
| Compliance standard | FDA Standards 21 CFR 892.1680 for stationary x-ray system ISO 13485 ISO 14971 ANSI/AAMI ES60601-1 IEC 62220-1-1 ISO 20417 | FDA Standards 21 CFR 892.1680 for stationary x-ray system ISO 13485 ISO 14971 ANSI/AAMI ES60601-1 IEC 62220-1-1 ISO 20417 | FDA Standards 21 CFR 892.1680 for stationary x-ray system European Medical Devices Directive (93/42/EEC) EN ISO 13485 ISO 14971 |
Page 11
Allengers Medical Systems Limited - 510(K) 7
| Feature | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| IEC 60601-1-2 IEC 62304 IEC 60601-1-6 IEC 62366-1 ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 15223-1 ANSI AAMI HE75 | IEC 60601-1-2 IEC 62304 IEC 60601-1-6 IEC 62366-1 ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 15223-1 ANSI AAMI HE75 | ANSI/AAMI ES60601-1 CAN/CSA C22.2 No. 60601-1:14 IEC 60601-1-2 IEC 62304 IEC 60601-1-6 IEC 62366-1 ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 15223-1 ANSI AAMI HE75 | |
| Technical | |||
| Dimensions (inch.) | G4336RWC (W)14X(H)17 G4343RWC (W)17X(H)17 T4336RWC: (W)14X(H)17 G4343RC: (W)17X(H)17 | G4336RWC: (W)14X(H)17 G4343RWC (W)17X(H)17 T4336RWC: (W)14X(H)17 G4343RC: (W)17X(H)17 | V14C: (W)14X(H)17 V17C: (W)17X(H)17 F14C: (W)14X(H)17 V17Ce: (W)17X(H)17 |
| Weight (Kg) | G4336RWC: 2.9 G4343RWC: 3.55 T4336RWC: 2.9 G4343RC: 3.9 | G4336RWC: 2.7 G4343RWC: 3.2 T4336RWC: 2.5 G4343RC: 3.6 | V14C: @3 V17C: @3 F14C: @2 V17Ce: @3.5 |
Page 12
Allengers Medical Systems Limited - 510(K) 8
| Feature | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Substrate | G4336RWC G4343RWC G4343RC | Glass | G4336RWC G4343RWC G4343RC |
| T4336RWC | Non-Glass | T4336RWC | |
| Scintillator | CsI | CsI | |
| A/D Conversion | 16 bit | 16 bit | |
| Pixels | G4336RWC: 2500 x 3052 G4343RWC: 3072 x 3072 T4336RWC: 2500 x 3052 G4343RC: 3072 x 3072 | G4336RWC: 2500 x 3052 G4343RWC: 3072 x 3072 T4336RWC: 2500 x 3052 G4343RC: 3072 x 3072 | |
| MTF @ 0.5 lp/mm (Max.) | 0.95 | G4343RC, G4343RWC, G4336RWC | 0.90 |
| 0.90 | T4336RWC | 0.85 | |
| MTF @1 lp/mm (Max.) | 0.70 | G4343RWC, G4336RWC, G4343RC | 0.76 |
| 0.69 | T4336RWC | 0.69 |
Page 13
Allengers Medical Systems Limited - 510(K) 9
| Feature | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| MTF @2 lp/mm (Max.) | 0.41 | G4343RC, G4343RWC, G4336RWC | 0.47 |
| 0.42 | T4336RWC | 0.42 | |
| DQE @ 0.5 lp/mm (Max.) | 0.85 | G4343RC, G4343RWC, G4336RWC | 0.78 |
| 0.79 | T4336RWC | 0.79 | |
| DQE @1 lp/mm (Max.) | 0.69 | G4343RWC, G4336RWC, G4343RC | 0.55 |
| 0.58 | T4336RWC | 0.58 | |
| DQE @2 lp/mm (Max.) | 0.54 | G4343RC, G4343RWC, G4336RWC | 0.47 |
| 0.49 | T4336RWC | 0.49 | |
| Thickness of Scintillator | 600 um | 400 um | |
| Sensitivity (Typ.) | 715 LSB/uGy | 574 LSB/uGy |
Page 14
Allengers Medical Systems Limited - 510(K) 10
| Feature | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Max. Resolution | 3.57 lp/mm | 3.57 lp/mm | 3.57 lp/mm |
| Interface | Wired: Gigabit Ethernet Wireless: IEEE802.11 ac /a/g/n | Wired: Gigabit Ethernet Wireless: IEEE802.11 ac /a/g/n | Wired: Gigabit Ethernet Wireless: IEEE802.11 ac /a/g/n |
| Power | Rechargeable Lithium Battery *G4343RC Have no Battery | Rechargeable Lithium Battery *G4343RC Have no Battery | Rechargeable Lithium Battery *V17Ce have No Battery |
| Biological | |||
| Biological safety | All material contact with patients is in accordance with ISO 10993. | All material contact with patients is in accordance with ISO 10993. | All material contact with patients is in accordance with ISO 10993. |
| Others | |||
| Accessories | Battery (Optional)* *G4343RC are not applicable Power supply (Adapter) SE cable (Back-up cable) Power Cord (Optional) Charger (Optional) Charger Adapter (Optional) AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR | Battery (Optional)* * G4343RC are not applicable Power supply (Adapter) SE cable (Back-up cable) Power Cord (Optional) Charger (Optional) Charger Adapter (Optional) AWS (Acquisition Workstation Software) Synergy DR FDX/ Synergy DR | Battery (Optional)* * V17Ce are not applicable Power supply (Adapter) SE cable (Back-up cable) Power Cord Power Cord (Optional) Charger (Optional) Charger Adapter(Optional) DROC Dongle (Optional) |
Page 15
Allengers Medical Systems Limited - 510(K) 11
PERFORMANCE DATA
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. Performance testing included functional testing i.e. Bench testing to evaluate the impact of different scintillator thicknesses on the image quality of FPDs. The non-clinical testing identified in the guidance for submission of 510(k)s for Solid state X-Ray imaging devices (SSXI) was performed and demonstrated adequate system performance and Imaging performance.
Non-clinical Performance Data: Wireless/ Wired X-Ray Flat Panel Detectors used with Accessory: "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 Device Software Functions (issued on June 14, 2023) was followed to evaluate the level of documentation as "Basic". 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. 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.
There are 4 models in this submission, G4336RWC, G4343RWC, T4336RWC, and G4343RC which are equivalent to the Predicate device. There is no change in accordance with Model Name, intended use, appearance & software. Only change in DQE, MTF, Sensitivity and thickness of Scintillator and due to this change there are no new safety and effectiveness issues being raised.
In conclusion, the modification of the 600μm CsI scintillator has been thoroughly evaluated and is deemed acceptable, as it does not significantly impact the safety, effectiveness, or intended use of the cleared model. This modification maintains compliance with fundamental scientific technology and the identified risk of electrical hazards was successfully mitigated.
Experimental results also confirm that the 600μm CsI provides superior noise performance and smoother image quality compared to the 400μm CsI, without clinically significant degradation of details or edges. Hence, this modification maintains diagnostic image quality as compared to the predicate. The data supports the substantial equivalence of the subject device to the predicate.