Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
American Mammographics, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023229 | S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), M | American Mammographics, Inc. | 2002-12-13 | 77 | 0 |
| K954521 | MAMMOSPOT PADDLE | American Mammographics, Inc. | 1995-10-24 | 26 | 0 |
| K903651 | AMI MAMMOSPOT | American Mammographics, Inc. | 1990-11-15 | 97 | 0 |
| K904517 | MAMMOSPOT 3 AND MAMMOSPOT 8 | American Mammographics, Inc. | 1990-11-15 | 43 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda