The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Agfa Mamoray Mammographic Cassette, Agfa Metal-bodied Cawo Cassette, Agfa Curix And Lightweight Cassette.
| Device ID | K023020 |
| 510k Number | K023020 |
| Device Name: | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE |
| Classification | Cassette, Radiographic Film |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29601 |
| Contact | Pamela K Gwynn |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-09-11 |
| Decision Date | 2002-09-26 |
| Summary: | summary |