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Hitachi America, Ltd., Particle Therapy Division

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3125-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A ProMay 27, 2024
Z-3127-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A ProdMay 27, 2024
Z-3126-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A ProMay 27, 2024