Medical Device Manufacturer · JP , Tokyo

Hitachi, Ltd., Health Care Company - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2015

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Hitachi, Ltd., Health Care Company Radiology ✕

4 devices

1-4 of 4

Cleared Apr 21, 2016

PROBEAT-V and accessories

Radiology · 126d

Cleared Nov 02, 2015

Radiology · 53d

Cleared Oct 02, 2015

Extended Range Shifter for PROBEAT-V

Radiology · 57d

Cleared Jun 01, 2015

Radiology · 34d