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 |