Hitachi , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K201042PROBEAT-CRJuly 13, 2020
K191801PROBEAT-CRSeptember 13, 2019
K172087SANGRAYOctober 27, 2017
K163505ARIETTA PRECISIONMay 30, 2017
K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersDecember 15, 2016
K162583ALOKA LISENDO 880November 17, 2016
K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryJuly 13, 2016
K060834PROBEAT WITH MGCSApril 19, 2006