The following data is part of a premarket notification filed by Careray Digital Medical Technology Co., Ltd. with the FDA for X-ray Flat Panel Detectors (careview 1800 Rf).
| Device ID | K221549 |
| 510k Number | K221549 |
| Device Name: | X-ray Flat Panel Detectors (CareView 1800 RF) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CareRay Digital Medical Technology Co., Ltd. A2-201/B3-501, Biobay,218 Xinghu Street, SuZhou Industrial Park, Suzhou, CN 215123 |
| Contact | Xu Wei |
| Correspondent | Xu Wei CareRay Digital Medical Technology Co., Ltd. A2-201/B3-501, Biobay,218 Xinghu Street, SuZhou Industrial Park, Suzhou, CN 215123 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-31 |
| Decision Date | 2022-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970597830271 | K221549 | 000 |