VITREAADVANCED
System, Image Processing, Radiological
VITAL IMAGES, INC.
The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Vitreaadvanced.
Pre-market Notification Details
| Device ID | K121213 |
| 510k Number | K121213 |
| Device Name: | VITREAADVANCED |
| Classification | System, Image Processing, Radiological |
| Applicant | VITAL IMAGES, INC. 5850 OPUS PARKWAY, SUITE 300 Minnetonka, MN 55343 -4414 |
| Contact | Daniel Biank |
| Correspondent | Daniel Biank 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 | 2012-04-20 |
| Decision Date | 2012-11-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853866003858 | K121213 | 000 |
Trademark Results [VITREAADVANCED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITREAADVANCED 85628344 4336216 Dead/Cancelled |
Vital Images, Inc. 2012-05-17 |
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