The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitrea Ct Transcatheter Aortic Valve Replacment (tavr) Planning.
| Device ID | K122578 |
| 510k Number | K122578 |
| Device Name: | VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING |
| Classification | System, Image Processing, Radiological |
| Applicant | VITAL IMAGES, INC. 5850 Opus Pkwy Ste 300 Minnetonka, MN 55343 |
| Contact | Ian Nemerov |
| Correspondent | Ian Nemerov VITAL IMAGES, INC. 5850 Opus Pkwy Ste 300 Minnetonka, MN 55343 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2013-02-25 |
| Summary: | summary |