K162148 is an FDA 510(k) clearance for the Allura Xper R9. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Philips Medical Systems Nethrlands BV (Best Noord-Brabant, NL). The FDA issued a Cleared decision on November 23, 2016, 114 days after receiving the submission on August 1, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K162148 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2016 |
| Decision Date | November 23, 2016 |
| Days to Decision | 114 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |