The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitrea Ct Colon Analysis.
| Device ID | K160150 |
| 510k Number | K160150 |
| Device Name: | Vitrea CT Colon Analysis |
| Classification | System, Image Processing, Radiological |
| Applicant | Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343 -4414 |
| Contact | Alexis Erazo |
| Correspondent | Alexis Erazo 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 | 2016-01-21 |
| Decision Date | 2016-03-16 |
| Summary: | summary |