Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

FDA Regulatory Profile

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

Recent 510(k) Clearances

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