The following data is part of a premarket notification filed by Vortech Data, Inc. with the FDA for Vortech's Film Digitizer, Fd-1.
| Device ID | K915362 |
| 510k Number | K915362 |
| Device Name: | VORTECH'S FILM DIGITIZER, FD-1 |
| Classification | System, X-ray, Stationary |
| Applicant | VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
| Contact | Manager, Qa |
| Correspondent | Manager, Qa VORTECH DATA, INC. 2929 NORTH CENTRAL EXPRESSWAY SUITE 101 Richardson, TX 75080 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-27 |
| Decision Date | 1992-04-06 |