The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for The Multimodality Advanced Vessel Analysis.
| Device ID | K203216 |
| 510k Number | K203216 |
| Device Name: | The Multimodality Advanced Vessel Analysis |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 Pc Best, NL 5684 |
| Contact | Vered Nitzan |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JAK |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | LNH |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2020-11-25 |