Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hitachi Healthcare Americas Corporation · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
182 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K181376 | ARIETTA 65 | Hitachi Healthcare Americas Corporation | 2018-07-18 | 55 | 0 |
| K173739 | ALOKA ARIETTA 850 | Hitachi Healthcare Americas Corporation | 2018-02-28 | 83 | 0 |
| K172110 | ECHELON OVAL V6.0A MRI System | Hitachi Healthcare Americas Corporation | 2018-01-11 | 182 | 0 |
| K171708 | ALOKA ARIETTA 850 | Hitachi Healthcare Americas Corporation | 2017-10-31 | 145 | 0 |
| K171738 | Supria True64 | Hitachi Healthcare Americas Corporation | 2017-08-18 | 67 | 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