Data / Medical devices / China / iRay Imaging Technology (Haining) Limited
iRay Imaging Technology (Haining) Limited: FDA-registered device maker in Haining Zhejiang, China, 1 510(k) clearance
iRay Imaging Technology (Haining) Limited is registered with the FDA (registration 3023546785) in Haining Zhejiang, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023546785
- Address
- 2nd floor and 3rd Floor, Building B, No. 2, Caohejing RD., Haining, Jiaxing, 314499 Zhejiang P.R. China, Haining Zhejiang, China, 314499
- Owner or operator
- iRay Imaging Technology (Haining) Limited (10085791)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- August 11, 2022
- Registered through
- 2026
- Brand names listed
- CRUX FR10, CRUX PR01, CRUX RF10, Canis014D07, Digital Radiographic Imaging Acquisition Software - DR (RiasDR), Venu1748V, high-voltage generator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Collimator, Automatic, Radiographic | IZW | 2 | Manufacturer | accessdata.fda.gov |
| Collimator, Manual, Radiographic | IZX | 2 | Manufacturer | accessdata.fda.gov |
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Contract manufacturer | accessdata.fda.gov |
| Unit, X-Ray, Extraoral With Timer | EHD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 17, 2023 | K223010 | Portable X-ray System | EHD | Substantially Equivalent | Iray Technology Taicang , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, High-Voltage, X-Ray, Diagnostic
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of Collimator, Manual, Radiographic
- All makers of Collimator, Automatic, Radiographic
- All makers of System, Image Processing, Radiological
- All makers of Unit, X-Ray, Extraoral With Timer
Updated January 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.