Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 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) |
|---|---|---|---|---|---|
| K140443 | ARIETTA 60/ARIETTAS60/ARIETTAV60 | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2014-06-16 | 115 | 0 |
| K134016 | ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCA | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2014-03-28 | 88 | 0 |
| K122537 | PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODE | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2013-04-12 | 235 | 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