FDA applicant
Hitachi Medical Corp. of America
FDA records 32 decisions for Hitachi Medical Corp. of America (Tarrytown, NY) from 1985 to 2000: 32 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 6 predicates, 2 of them its own earlier devices. No 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 Medical Corp. of America’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hitachi Medical Corp. of America since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hitachi Medical Corp. of America’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.