K172307 is an FDA 510(k) clearance for the Dynamic Coronary Roadmap 2.0. 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 October 24, 2017, 85 days after receiving the submission on July 31, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K172307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2017 |
| Decision Date | October 24, 2017 |
| Days to Decision | 85 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 |