The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Universal Stand For Film Changer.
| Device ID | K853928 |
| 510k Number | K853928 |
| Device Name: | UNIVERSAL STAND FOR FILM CHANGER |
| Classification | Changer, Radiographic Film/cassette |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Tamada |
| Correspondent | Tamada CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | KPX |
| CFR Regulation Number | 892.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-10-28 |