The following data is part of a premarket notification filed by Jamieson Film Co. with the FDA for Vanguard Xr-350 Cineangiogram Projector.
| Device ID | K953563 |
| 510k Number | K953563 |
| Device Name: | VANGUARD XR-350 CINEANGIOGRAM PROJECTOR |
| Classification | System, X-ray, Angiographic |
| Applicant | JAMIESON FILM CO. 10425 OLYMPIC DR. Dallas, TX 75220 -4427 |
| Contact | George Leon |
| Correspondent | George Leon JAMIESON FILM CO. 10425 OLYMPIC DR. Dallas, TX 75220 -4427 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1995-10-05 |