Iray Group
Manufacturer and brand owner in Shanghai, China. 4 device types, 15 products catalogued.
iRay Group is a specification developer holding a current FDA establishment registration. The registration covers System, Image Processing, Radiological, System, X-Ray, Extraoral Source, Digital and 2 other device types. 15 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
4device types registered with the FDA
15products catalogued under its own name
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3013186032 |
| FEI number | 3013186032 |
| DUNS | 421363780 |
| Establishment type | Specification developer, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 奕瑞电子科技集团股份有限公司 |
|---|---|
| Source | EMIS company database |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | No.999, Huanqiao Road, Pudong New Area |
| Postal code | 201315 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | Venu1748V-WF, DRX-LC, Mars1417V-PSI, Mars1417X Wireless Digital Flat Panel Detector, Mano4336F Wireless Digital Flat Panel Detector, Mano4336A Wireless Digital Flat Panel Detector, Mars1013X and 17 more | 2016 | 13 |
| System, Image Processing, Radiological | Class 2 | Digital Radiographic Imaging Acquisition Software – DR (RiasDR) | 2025 | 16 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | iScan | 2025 | 36 |
| System, X-Ray, Extraoral Source, Digital | Class 2 | CS 6200 Digital Intraoral X-Ray Sensor, Pluto0002XW, Pluto0000X Digital Intraoral X-ray Imaging System, Pluto0015X Digital Intraoral X-ray Imaging System, Pluto0002X Digital Intraoral X-ray Imaging System, Pluto0001X Digital Intraoral X-ray Imaging System | 2021 | 10 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Wireless Digital Flat Panel Detector | MQB | 27 |
| Digital flat panel detector | MQB | 10 |
| Digital Intraoral X-ray Imaging System | MUH | 10 |
| Flat Panel Detector | MQB | 3 |
| Wireless Digital Flat Panel Detector(19 pin) | MQB | 2 |
| Mano4336A Wireless Digital Flat Panel Detector | MQB | 1 |
| Mano2530F Wireless Digital Flat Panel Detector | MQB | 1 |
| Mano4343A Wireless Digital Flat Panel Detector | MQB | 1 |
| Digital Intraoral X-Ray Sensor | MUH | 1 |
| Mano2530A Wireless Digital Flat Panel Detector | MQB | 1 |
| Mano4343F Wireless Digital Flat Panel Detector | MQB | 1 |
| iRay | NOF | 1 |
| Digital Radiographic Imaging Acquisition Software – DR (RiasDR) | LLZ | 1 |
| Mano4336F Wireless Digital Flat Panel Detector | MQB | 1 |
| Digital Wireless Intraoral X-Ray Sensor | MUH | 1 |
Clearances
No clearance names iRay Group as applicant. 19 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251038 | 2025-08-06 | LLZ | Traditional | Shen Zhen Cambridge-Hit Co., Ltd. |
| K230998 | 2023-10-20 | MUH | Special | iRay Imaging Technology (Haining) Limited |
| K230811 | 2023-04-21 | MUH | Special | iRay Imaging Technology (Haining) Limited |
| K230059 | 2023-02-03 | MQB | Special | Ray Imaging Technology (Haining) Limited |
| K222886 | 2022-10-20 | MQB | Special | Iray Technology Taicang, Ltd. |
| K221714 | 2022-06-29 | MQB | Special | Iray Technology Taicang, Ltd. |
| K221345 | 2022-06-16 | MQB | Special | Iray Technology Taicang, Ltd. |
| K220536 | 2022-04-28 | MQB | Traditional | Iray Technology Taicang, Ltd. |
| K220668 | 2022-04-01 | MQB | Special | Iray Technology Taicang, Ltd. |
| K210312 | 2021-04-23 | MUH | Traditional | Iray Technology Taicang, Ltd. |
| K210316 | 2021-03-03 | MQB | Special | Iray Technology Taicang, Ltd. |
| K210314 | 2021-03-02 | MQB | Special | Iray Technology Taicang, Ltd. |
| K201043 | 2020-05-12 | MQB | Special | Iray Technology Taicang, Ltd. |
| K201004 | 2020-05-01 | MQB | Special | Iray Technology Taicang, Ltd. |
| K183713 | 2019-01-09 | MQB | Special | Iray Technology Taicang, Ltd. |
| K183422 | 2019-01-09 | MQB | Special | Iray Technology Taicang, Ltd. |
| K182550 | 2018-10-17 | MQB | Traditional | Iray Technology Taicang, Ltd. |
| K182551 | 2018-10-17 | MQB | Traditional | Iray Technology Taicang, Ltd. |
| K161730 | 2016-12-08 | MQB | Traditional | Iray Technology (Shanghai), Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Digital X-ray core components, High-voltage generators, X-ray tubes, Micro-display backplanes, AI glasses/VR headset components |
| Export markets | Medical, industrial NDT, security applications globally |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.