The following data is part of a premarket notification filed by Vital Images, Inc with the FDA for Mr Core Software.
| Device ID | K151115 |
| 510k Number | K151115 |
| Device Name: | MR Core Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Vital Images, Inc 5850 Opus Parkway Suite 300 Minnetonka, MN 55343 -4414 |
| Contact | Parthiv Shah |
| Correspondent | Parthiv Shah 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 | 2015-04-27 |
| Decision Date | 2015-06-03 |
| Summary: | summary |