K160301 is an FDA 510(k) clearance for the Platinum dRF Imaging System. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Apelem-Dms Group (Nimes 30005, FR). The FDA issued a Cleared decision on March 4, 2016, 29 days after receiving the submission on February 4, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K160301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2016 |
| Decision Date | March 04, 2016 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA - System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |