The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Dynamic Coronary Roadmap 2.0.
| Device ID | K172307 |
| 510k Number | K172307 |
| Device Name: | Dynamic Coronary Roadmap 2.0 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Contact | Laura Wortel |
| Correspondent | Laura Wortel Philips Medical Systems Nederland B.V. Veenpluis 4-6 Best, NL 5684 Pc |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-31 |
| Decision Date | 2017-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086777 | K172307 | 000 |