FDA applicant
Hitachi Medical Corp.
FDA records 12 decisions for Hitachi Medical Corp. (Tarrytown, NY) from 1982 to 2016: 12 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and ITX (Transducer, Ultrasonic, Diagnostic). Its devices cite 5 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Hitachi Medical Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hitachi Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Hitachi Medical Corp.’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.