The following data is part of a premarket notification filed by Umi Intl. with the FDA for Umi X-ray Film Cassette.
| Device ID | K971431 |
| 510k Number | K971431 |
| Device Name: | UMI X-RAY FILM CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | UMI INTL. 18 ROBERTS DR. Bedford, MA 01730 |
| Contact | Kwang Chae Jung |
| Correspondent | Kwang Chae Jung UMI INTL. 18 ROBERTS DR. Bedford, MA 01730 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-17 |
| Decision Date | 1997-05-20 |