FDA applicant
Hitachi Healthcare Americas
FDA records 17 decisions for Hitachi Healthcare Americas (Twinsburg, OH) from 2017 to 2021: 17 510(k) clearances. Most are in product codes IYN (System, Imaging, Pulsed Doppler, Ultrasonic) and JAK (System, X-Ray, Tomography, Computed). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 11 of them its own earlier devices. 9 recalls are linked to its devices.
FDA’s records also spell it “Hitachi Healthcare Americas Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hitachi Healthcare Americas’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
2in 2022
Class I Class II/III not classified
Planning a device like Hitachi Healthcare Americas’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.