The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Allura 3d-ra Rel 6, 3d Roadmap Rel 1, Mr-ct Roadmap Rel 1.
| Device ID | K121772 |
| 510k Number | K121772 |
| Device Name: | ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Contact | Frans Jacobs |
| Correspondent | Frans Jacobs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc |
| Product Code | OWB |
| Subsequent Product Code | JAK |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2013-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838084766 | K121772 | 000 |
| 00884838059238 | K121772 | 000 |
| 00884838059221 | K121772 | 000 |
| 00884838059214 | K121772 | 000 |