The following data is part of a premarket notification filed by Barcoview Mis Edinburgh with the FDA for Voxar 3d Enterprise With Cardiametrix.
| Device ID | K061326 |
| 510k Number | K061326 |
| Device Name: | VOXAR 3D ENTERPRISE WITH CARDIAMETRIX |
| Classification | System, Image Processing, Radiological |
| Applicant | BARCOVIEW MIS EDINBURGH BONNINGTON BOND, 2 ANDERSON PL Edinburgh, Lothian, GB Eh6 5np |
| Contact | Neil Phillips |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-05-10 |
| Decision Date | 2006-05-25 |