K173828 is an FDA 510(k) clearance for the GU60A & GU60A-65. 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 January 12, 2018, 25 days after receiving the submission on December 18, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K173828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2017 |
| Decision Date | January 12, 2018 |
| Days to Decision | 25 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 |