The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitrea Ct Dual Energy Image View.
| Device ID | K161157 |
| 510k Number | K161157 |
| Device Name: | Vitrea CT Dual Energy Image View |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | VITAL IMAGES, INC. 5850 OPUS PARKWAY SITE 300 Minnetonka, MN 55343 -4414 |
| Contact | Alexis Erazo |
| Correspondent | Vincent Swenson VITAL IMAGES, INC. 5850 OPUS PARKWAY SITE 300 Minnetonka, MN 55343 -4414 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-11-03 |
| Summary: | summary |