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 1800cwe /careview 1500cwe).
| Device ID | K201932 |
| 510k Number | K201932 |
| Device Name: | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970597830745 | K201932 | 000 |
| 06970597830172 | K201932 | 000 |