K201932 is an FDA 510(k) clearance for the X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe). This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Careray Digital Medical System Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 7, 2020, 25 days after receiving the submission on July 13, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K201932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2020 |
| Decision Date | August 07, 2020 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |