The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitreaview.
| Device ID | K122136 |
| 510k Number | K122136 |
| Device Name: | VITREAVIEW |
| 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 | 2012-07-18 |
| Decision Date | 2012-09-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITREAVIEW 85542448 4209683 Dead/Cancelled |
Vital Images, Inc. 2012-02-14 |