Medical Device Manufacturer · US , Twinsburg , OH

Hitachi Healthcare Americas Corporation - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2017

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hitachi Healthcare Americas Corporation Radiology ✕

5 devices

1-5 of 5

Cleared Jul 18, 2018

Radiology · 55d

Cleared Feb 28, 2018

ALOKA ARIETTA 850

Radiology · 83d

Cleared Jan 11, 2018

ECHELON OVAL V6.0A MRI System

Radiology · 182d

Cleared Oct 31, 2017

ALOKA ARIETTA 850

Radiology · 145d

Cleared Aug 18, 2017

Radiology · 67d