The following data is part of a premarket notification filed by Vital Images, Inc. with the FDA for Voxelview.
| Device ID | K953259 |
| 510k Number | K953259 |
| Device Name: | VOXELVIEW |
| Classification | System, Image Processing, Radiological |
| Applicant | VITAL IMAGES, INC. 2575 UNIVERSITY AVE. Saint Paul, MN 55114 -1024 |
| Contact | Bruce A Macfarland |
| Correspondent | Bruce A Macfarland VITAL IMAGES, INC. 2575 UNIVERSITY AVE. Saint Paul, MN 55114 -1024 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-12 |
| Decision Date | 1995-11-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VOXELVIEW 74048935 1660587 Dead/Cancelled |
Vital Images, Inc. 1990-04-16 |