The following data is part of a premarket notification filed by J.p.i. Chicago Co. with the FDA for X-ray Film Cassette.
| Device ID | K945858 |
| 510k Number | K945858 |
| Device Name: | X-RAY FILM CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | J.P.I. CHICAGO CO. 2451 UNITE LN. Elk Grove, IL 60007 |
| Contact | J O'grady |
| Correspondent | J O'grady J.P.I. CHICAGO CO. 2451 UNITE LN. Elk Grove, IL 60007 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-01 |
| Decision Date | 1995-03-21 |