The following data is part of a premarket notification filed by Careray Digital Medical System Co., Ltd. with the FDA for Careview 1800cw X-ray Flat Panel Detectors.
| Device ID | K172581 |
| 510k Number | K172581 |
| Device Name: | CareView 1800Cw X-ray Flat Panel Detectors |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CareRay Digital Medical System Co., Ltd. B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park Suzhou, CN 215123 |
| Contact | Xu Wei |
| Correspondent | Xu Wei CareRay Digital Medical System Co., Ltd. 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 | 2017-08-28 |
| Decision Date | 2017-09-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970597830257 | K172581 | 000 |