Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitsubishi Electronics America, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973963 | 120 LEAF MULTILEAF COLLIMATOR | Mitsubishi Electronics America, Inc. | 1998-01-14 | 90 | 0 |
| K970564 | DYNAMIC WEDGE | Mitsubishi Electronics America, Inc. | 1997-05-12 | 88 | 0 |
| K970137 | EXL-12SP,12DP,15DP,20DP LINAC | Mitsubishi Electronics America, Inc. | 1997-04-15 | 90 | 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