Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hitachi Aloka Medical, Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
142 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | Hitachi Aloka Medical, Ltd. | 2015-01-14 | 142 | 0 |
| K140854 | INTRA-OPERATIVE ULTRASOUND TRANSDUCER | Hitachi Aloka Medical, Ltd. | 2014-06-11 | 69 | 0 |
| K140639 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Hitachi Aloka Medical, Ltd. | 2014-04-16 | 35 | 0 |
| K130308 | NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM | Hitachi Aloka Medical, Ltd. | 2013-04-05 | 57 | 0 |
| K123828 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Hitachi Aloka Medical, Ltd. | 2013-01-18 | 37 | 0 |
| K122341 | PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F | Hitachi Aloka Medical, Ltd. | 2012-09-26 | 55 | 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