FDA applicant
Hitachi, Ltd.
FDA records 8 decisions for Hitachi, Ltd. (Wallingford, CT) from 2006 to 2020: 8 510(k) clearances. Most are in product codes LHN (System, Radiation Therapy, Charged-Particle…) and IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 74 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hitachi, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Hitachi, Ltd.’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.