K173612 is an FDA 510(k) clearance for the Optima XR646 HD. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 11, 2017, 19 days after receiving the submission on November 22, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K173612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2017 |
| Decision Date | December 11, 2017 |
| Days to Decision | 19 days |
| Submission Type | Special |
| 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 |