The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Digital Subtraction Antiography Phantom 76-700/711.
| Device ID | K851812 |
| 510k Number | K851812 |
| Device Name: | DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 |
| Classification | Test-pattern, Radiographic |
| Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Contact | Glasser |
| Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
| Product Code | IXF |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-06-05 |