Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mitsubishi Heavy Industries, Ltd. · 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) |
|---|---|---|---|---|---|
| K152867 | MHI-TM2000 Linear Accelerator System, VERO, Imavis | Mitsubishi Heavy Industries, Ltd. | 2015-10-21 | 21 | 2 |
| K122450 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS | Mitsubishi Heavy Industries, Ltd. | 2012-10-03 | 51 | 6 |
| K072047 | MHI-TM2000 LINEAR ACCELERATOR SYSTEM | Mitsubishi Heavy Industries, Ltd. | 2007-08-29 | 35 | 6 |
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