K182183 is an FDA 510(k) clearance for the GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; 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 December 7, 2018, 116 days after receiving the submission on August 13, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K182183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2018 |
| Decision Date | December 07, 2018 |
| Days to Decision | 116 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 |