The following data is part of a premarket notification filed by Agfa-gevaert, Inc. with the FDA for Mammography System And Cassette.
| Device ID | K790273 |
| 510k Number | K790273 |
| Device Name: | MAMMOGRAPHY SYSTEM AND CASSETTE |
| Classification | System, X-ray, Mammographic |
| Applicant | AGFA-GEVAERT, INC. TEGERNSEER LANDSTRASSE 161 8000 MUCRCHON 90 West Germany, DE |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-08 |
| Decision Date | 1979-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414904026007 | K790273 | 000 |
| 05414904008898 | K790273 | 000 |
| 05414904008942 | K790273 | 000 |
| 05414904008959 | K790273 | 000 |
| 05414904008966 | K790273 | 000 |
| 05414904009345 | K790273 | 000 |
| 05414904009796 | K790273 | 000 |
| 05414904009802 | K790273 | 000 |
| 05414904024539 | K790273 | 000 |
| 05414904024690 | K790273 | 000 |
| 05414904008881 | K790273 | 000 |