Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hitachi , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
167 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201042 | PROBEAT-CR | Hitachi , Ltd. | 2020-07-13 | 84 | 1 |
| K191801 | PROBEAT-CR | Hitachi , Ltd. | 2019-09-13 | 72 | 1 |
| K172087 | SANGRAY | Hitachi , Ltd. | 2017-10-27 | 108 | 0 |
| K163505 | ARIETTA PRECISION | Hitachi , Ltd. | 2017-05-30 | 167 | 0 |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducer | Hitachi , Ltd. | 2016-12-15 | 59 | 0 |
| K162583 | ALOKA LISENDO 880 | Hitachi , Ltd. | 2016-11-17 | 63 | 0 |
| K161163 | PROBEAT-V Proton Beam Therapy System with X-ray Limiting Acc | Hitachi , Ltd. | 2016-07-13 | 79 | 0 |
| K060834 | PROBEAT WITH MGCS | Hitachi , Ltd. | 2006-04-19 | 23 | 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