FDA applicant
Hitachi, Ltd., Health Care Company
FDA records 4 decisions for Hitachi, Ltd., Health Care Company (Tokyo, JP) from 2015 to 2016: 4 510(k) clearances. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 7 predicates, 4 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, Ltd., Health Care Company’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Hitachi, Ltd., Health Care Company’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.