Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W)
by Iray Technology Taicang, Ltd.
510(k) K201043
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK201043 | Date12 May 2020 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- MQB
- FDA applicant
- Iray Technology Taicang , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is a Solid State X-Ray Imager (Flat Panel/Digital Imager), classified as a Class II medical device. It functions as a wireless digital flat panel detector designed for radiographic imaging, converting X-ray exposure into digital signals for real-time visualization. The detector employs amorphous silicon (a-Si) technology to capture high-resolution images, suitable for both general radiography and specialized applications in radiology.
The Wireless Digital Flat Panel Detector (Models: Mars1717V-VSI, Mano4343W) is intended for use in radiology settings, interfacing with digital radiography (DR) systems for image acquisition. Supplied as a reusable device, it operates wirelessly with a battery-powered design, ensuring portability and ease of integration into existing systems. The detector is MRI-unsafe and requires proper storage to maintain functionality. Authorized under FDA 510K and MDR, it adheres to regulatory standards for radiologic imaging devices.
Other devices from Iray Technology Taicang, Ltd.
Questions
AI-generated answers, 20 Sep 2026
What types of imaging procedures can this wireless digital flat panel detector be used for in a clinical setting?
This device is designed for radiographic imaging and is suitable for general radiography as well as specialized applications in radiology. It converts X-ray exposure into digital signals for real-time visualization, making it versatile for capturing high-resolution images in various diagnostic scenarios.
Is this detector reusable or single-use, and how should it be maintained?
The Wireless Digital Flat Panel Detector is supplied as a reusable device. Since it is battery-powered and wireless, it requires proper storage to maintain functionality, though specific maintenance instructions are not detailed in the provided data. Regular cleaning and adherence to manufacturer guidelines will be necessary to ensure longevity and reliability.
Can this device be used in an MRI environment, and what safety precautions should be taken?
No, this device is explicitly labeled as MRI-unsafe, meaning it should never be used or stored in an MRI environment. Proper storage away from MRI facilities is required to prevent interference or safety hazards.
What regulatory pathways has this device undergone, and how does that affect its use?
The device has been authorized under FDA 510K and MDR (Medical Device Regulation) pathways, confirming compliance with regulatory standards for radiologic imaging devices. This means it meets the necessary safety and performance requirements for use in radiology settings, though actual clinical use is governed by local healthcare regulations and institutional protocols.
Are there multiple models available, and how do I determine which one fits my needs?
Yes, this device is available in two models: Mars1717V-VSI and Mano4343W. The choice depends on compatibility with your existing digital radiography (DR) system and specific imaging requirements. Consult your radiology department’s technical specifications or contact the manufacturer for guidance on selecting the appropriate model for your workflow.