FDA applicant
Hitachi Aloka Medical, Ltd.
FDA records 6 decisions for Hitachi Aloka Medical, Ltd. (Wallingford, CT) from 2012 to 2015: 6 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 10 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hitachi Aloka Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Hitachi Aloka Medical, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Hitachi”
FDA records each applicant name separately; these may or may not be the same firm.