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 |