The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitrea Ct Myocardial Analysis.
| Device ID | K112531 |
| 510k Number | K112531 |
| Device Name: | VITREA CT MYOCARDIAL ANALYSIS |
| Classification | System, Image Processing, Radiological |
| Applicant | VITAL IMAGES, INC. 5850 OPUS PARKWAY, SUITE 300 Minnetonka, MN 55343 -4414 |
| Contact | Daniel Biank |
| Correspondent | Daniel Biank VITAL IMAGES, INC. 5850 OPUS PARKWAY, SUITE 300 Minnetonka, MN 55343 -4414 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-31 |
| Decision Date | 2011-11-18 |
| Summary: | summary |