FDA applicant
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
FDA records 2 decisions for Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha (Kashiwa-Shi, JP) from 2022 to 2024: 2 510(k) clearances. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 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. Radiation Oncology Systems, Kashiwanoha’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Hitachi, Ltd. Radiation Oncology…’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.