The following data is part of a premarket notification filed by Barcoview Mis Edinburgh with the FDA for Voxar 3d Enterprise, Model 6.1.
| Device ID | K060505 |
| 510k Number | K060505 |
| Device Name: | VOXAR 3D ENTERPRISE, MODEL 6.1 |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCOVIEW MIS EDINBURGH BONNINGTON BOND, 2 ANDERSON PL Edinburgh, GB Eh6 5np |
| Contact | Neil Phillips |
| Correspondent | Neil Phillips BARCOVIEW MIS EDINBURGH BONNINGTON BOND, 2 ANDERSON PL Edinburgh, GB Eh6 5np |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-03-29 |