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 |