FDA applicant
Hitachi Aloka Medical America, Inc.
FDA records 3 decisions for Hitachi Aloka Medical America, Inc. (Wallingford, CT) from 2014 to 2016: 3 510(k) clearances. Most are in product codes ITX (Transducer, Ultrasonic, Diagnostic) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 6 predicates, 0 of them its own earlier devices. 1 recall is 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 America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2016
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Hitachi Aloka Medical America, Inc.’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.