Medical Device Manufacturer · US , Twinsburg , OH

Hitachi Healthcare Americas - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2018

12

Total

12

Cleared

0

Denied

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

1 devices

1-1 of 1

Cleared Aug 17, 2018

Optical Topography System ETG-4100

Neurology · 365d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 22, 2026