Medical Device Manufacturer · US , Washington, Dc , DC

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

8 submissions · 8 cleared · Since 2006

Recent clearances: PROBEAT-CR, PROBEAT-CR

Total

Cleared

Denied

Hitachi , Ltd. has 8 FDA 510(k) cleared medical devices. Based in Washington, Dc, US.

Historical record: 8 cleared submissions from 2006 to 2020. Primary specialty: Radiology.

Browse the FDA 510(k) cleared devices submitted by Hitachi , Ltd. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Hogan Lovells US LLP and Hogan & Lovells US LLP.

Hitachi , Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Hitachi , Ltd.

8 devices

1-8 of 8

ARIETTA Prologue Diagnostic Ultrasound system and Transducers

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: May 28, 2026

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

FDA 510(k) Regulatory Record - Hitachi , Ltd.

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