The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Ct Transcatheter Aortic Valve Implantation (tavi) Planning Application.
| Device ID | K132524 |
| 510k Number | K132524 |
| Device Name: | CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS 595 MINER ROAD Cleveland, OH 44143 |
| Contact | Susan Quick |
| Correspondent | Susan Quick PHILIPS MEDICAL SYSTEMS 595 MINER ROAD Cleveland, OH 44143 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2014-06-13 |
| Summary: | summary |