The following data is part of a premarket notification filed by Jpi America, Inc. with the FDA for Jpi X-ray Film Cassette.
| Device ID | K945328 |
| 510k Number | K945328 |
| Device Name: | JPI X-RAY FILM CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | JPI AMERICA, INC. 41-02 BELL BLVD. SUITE LL3 Bayside, NY 11361 |
| Contact | Ki M Lee |
| Correspondent | Ki M Lee JPI AMERICA, INC. 41-02 BELL BLVD. SUITE LL3 Bayside, NY 11361 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1995-01-20 |