K143270 is an FDA 510(k) clearance for the Optima XR646. 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 February 18, 2015, 97 days after receiving the submission on November 13, 2014.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K143270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2014 |
| Decision Date | February 18, 2015 |
| Days to Decision | 97 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 |