The following data is part of a premarket notification filed by Careray Digital Medical System Co., Ltd. with the FDA for X-ray Flat Panel Detectors/careview 3600rf.
| Device ID | K202995 |
| 510k Number | K202995 |
| Device Name: | X-ray Flat Panel Detectors/CareView 3600RF |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CareRay Digital Medical System Co., Ltd. A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park Suzhou, CN 215123 |
| Contact | Leilei Li |
| Correspondent | Leilei Li CareRay Digital Medical System 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 | 2020-10-01 |
| Decision Date | 2021-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970597830479 | K202995 | 000 |