iRay Imaging Technology (Haining) Limited
Haining Zhejiang, CN
iRay Imaging Technology (Haining) Limited appears in FDA device records in Haining Zhejiang, CN. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for iRay Imaging Technology (Haining) Limited between 2023 and 2025. The busiest year on record is 2023, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252911 | Lux HD 2530 detector (Lux HD 2530) | MQB | Substantially Equivalent | |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | MQB | Substantially Equivalent | |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | MUH | Substantially Equivalent | |
| K230811 | Digital Intraoral X-Ray Sensor | MUH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3023546785 | 3023546785 | iRay Imaging Technology (Haining) Limited | 2nd floor and 3rd Floor, Building B, No. 2, Caohejing RD., Haining, Jiaxing, 314499 Zhejiang P.R. China, Haining Zhejiang 314499 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain