The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Omniplane 200 Film Changer System.
| Device ID | K874451 |
| 510k Number | K874451 |
| Device Name: | OMNIPLANE 200 FILM CHANGER SYSTEM |
| Classification | Programmer, Changer, Film/cassette, Radiographic |
| Applicant | MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Contact | Ruey C Dempsey |
| Correspondent | Ruey C Dempsey MEDRAD, INC. 271 KAPPA DR. Pittsburgh, PA 15238 -2870 |
| Product Code | IZP |
| CFR Regulation Number | 892.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1988-02-11 |