The following data is part of a premarket notification filed by Vital Images, Inc with the FDA for Vitreaview.
| Device ID | K150738 |
| 510k Number | K150738 |
| Device Name: | VitreaView |
| 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 | 2015-03-20 |
| Decision Date | 2015-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853866003285 | K150738 | 000 |
| 00853866003261 | K150738 | 000 |
| 00853866003230 | K150738 | 000 |
| 00853866003223 | K150738 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITREAVIEW 85542448 4209683 Dead/Cancelled |
Vital Images, Inc. 2012-02-14 |