Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

FDA Regulatory Profile

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha appears in FDA public data with 2 recalls, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1430-2026, Class II) was initiated on February 6, 2026. Its most recent 510(k) clearance was granted on January 12, 2024.

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Known Names

hitachi, ltd. radiation oncology systems, kashiwanoha, hitachi ltd., radiation oncology systems, kashiwanoha

Recent Recalls

NumberClassProductDate
Z-1430-2026Class IIBrand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRFebruary 6, 2026
Z-1429-2026Class IIBrand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FRFebruary 6, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K232032PROBEAT-FRJanuary 12, 2024
K220883Small Field ApplicatorDecember 15, 2022