The following data is part of a premarket notification filed by Voxel with the FDA for Voxcam.
| Device ID | K954198 |
| 510k Number | K954198 |
| Device Name: | VOXCAM |
| Classification | Camera, Multi Format, Radiological |
| 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 | LMC |
| CFR Regulation Number | 892.2040 [🔎] |
| 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 |
|---|---|
![]() VOXCAM 73768924 1560609 Dead/Cancelled |
VOXEL 1988-12-12 |