The following data is part of a premarket notification filed by Voxel with the FDA for Voxgram.
| Device ID | K954200 |
| 510k Number | K954200 |
| Device Name: | VOXGRAM |
| Classification | Film, Radiographic |
| Applicant | VOXEL 26081 MERIT CIRCLE, #117 Laguna Hills, CA 92653 |
| Contact | Murray Rudin |
| Correspondent | Murray Rudin VOXEL 26081 MERIT CIRCLE, #117 Laguna Hills, CA 92653 |
| Product Code | IWZ |
| CFR Regulation Number | 892.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-06 |
| Decision Date | 1995-09-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VOXGRAM 73768925 1574510 Dead/Cancelled |
VOXEL 1988-12-12 |