K160997 is an FDA 510(k) clearance for the GC85A. This device is classified as a System, X-ray, Stationary (Class II — Special Controls, product code KPR).
Submitted by Samsung Electronics Co., Ltd. (Suwon-Si,, KR). The FDA issued a Cleared decision on July 6, 2016, 86 days after receiving the submission on April 11, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K160997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2016 |
| Decision Date | July 06, 2016 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |