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 |