K162178 is an FDA 510(k) clearance for the CareView 1500P X-ray Flat Panel Detectors. 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 September 1, 2016, 28 days after receiving the submission on August 4, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K162178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2016 |
| Decision Date | September 01, 2016 |
| Days to Decision | 28 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 |