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US
Last updated May 27, 2026
What iRay Imaging Technology Taicang Limited makes
The company manufactures indirect flat panel x-ray detectors, including models such as the iRay series and Mano variants (e.g., Mano4336W and Mano4343W). These devices are designed for digital radiography applications, converting x-ray images into electronic signals for medical imaging systems.
The portfolio consists of Class II medical devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States and adheres to applicable regulatory requirements for these imaging technologies.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does iRay Imaging Technology Taicang Limited manufacture?
iRay Imaging Technology Taicang Limited specializes in indirect flat panel x-ray detectors, which are used in digital radiography systems. These detectors capture x-ray images and convert them into electronic signals for medical imaging purposes, enabling clearer and more efficient diagnostic imaging.
Where is iRay Imaging Technology Taicang Limited based?
The company is based in the United States, where it develops and manufactures its indirect flat panel x-ray detectors. This location aligns with regulatory requirements for medical device production and distribution in North America.
Which regulatory registries list iRay Imaging Technology Taicang Limited’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory standards. This registry helps healthcare providers and regulators identify and verify the devices in use.
How are iRay Imaging Technology Taicang Limited’s devices classified under medical device regulations?
All of iRay Imaging Technology Taicang Limited’s devices fall under Class II classification in the U.S. regulatory framework. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as indirect flat panel x-ray detectors.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 543860743
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iRay(k) | Mars1417V-TSI | FDA UDI | Class II | Active |
| Mano4336W(k) | Mano4336W | FDA UDI | Class II | Active |
| iRay | Mars1717XF-CSI | FDA UDI | Class II | Active |
| Mano4336W(k Taicang) | Mano4336W | FDA UDI | Class II | Active |
| iRay | Mars1417XF-CSI | FDA UDI | Class II | Active |
| iRay | Mars1417V-TSI | FDA UDI | Class II | Active |
| iRay | Mars1717V-VSI | FDA UDI | Class II | Active |
| Mano4336W | Mano4336W | FDA UDI | Class II | Active |
| iRay | Mars1717XF-GSI | FDA UDI | Class II | Active |
| Mano4343W(k Taicang) | Mano4343W | FDA UDI | Class II | Active |
| iRay(k Taicang) | Mars1417V-TSI | FDA UDI | Class II | Active |
| iRay(k) | Mars1717V-VSI | FDA UDI | Class II | Active |
| iRay | Mars1417XF-GSI | FDA UDI | Class II | Active |
| iRay(k Taicang) | Mars1717V-VSI | FDA UDI | Class II | Active |
| Mano4343W(k) | Mano4343W | FDA UDI | Class II | Active |
| Mano4343W | Mano4343W | FDA UDI | Class II | Active |
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