K172822 is an FDA 510(k) clearance for the Azurion series R1.2. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Philips Medical Systems Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on November 22, 2017, 65 days after receiving the submission on September 18, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K172822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2017 |
| Decision Date | November 22, 2017 |
| Days to Decision | 65 days |
| Submission Type | Special |
| 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 |