Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitsubishi Intl. Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
230 daysmedian FDA review time
249 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961214 | MULTI LEAF COLLIMATOR | Mitsubishi Intl. Corp. | 1996-08-06 | 131 | 0 |
| K952314 | EXL-12SP & 12DP LINAC | Mitsubishi Intl. Corp. | 1996-01-17 | 245 | 0 |
| K952108 | EXL-15DP & 20-DP LINAC | Mitsubishi Intl. Corp. | 1995-12-21 | 230 | 0 |
| K880200 | EXL-14 MEDICAL LINEAR ACCELERATOR | Mitsubishi Intl. Corp. | 1988-08-04 | 206 | 0 |
| K873398 | EXL-22DP X-RAY RADIATION THERAPY SYSTEM | Mitsubishi Intl. Corp. | 1988-04-29 | 249 | 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