Medical Device Manufacturer · JP , Hino-Shi, Tokyo

Ge Healthcare Japan Corporation - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2011

Recent clearances: True Definition DL, True Enhance DL, Deep Learning Image Reconstruction

Total

Cleared

Denied

Ge Healthcare Japan Corporation has 10 FDA 510(k) cleared radiology devices. Based in Hino-Shi, Tokyo, JP.

Latest FDA clearance: Mar 2026. Active since 2011.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Ge Medical Systems, LLC and Ge Hangwei Medical Systems Co., Ltd..

Ge Healthcare Japan Corporation is one of 79 FDA 510(k) medical device manufacturers from Japan in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Ge Healthcare Japan Corporation

10 devices

1-10 of 10

Deep Learning Image Reconstruction

K230807 · JAK

Radiology · 28d

Cleared Jul 29, 2022

Deep Learning Image Reconstruction

Deep Learning Image Reconstruction

Deep Learning Image Reconstruction

DISCOVERY MR750W 3.0T

K103327 · LNH

Radiology · 322d

Data Source

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

Last updated: Apr 27, 2026

Ge Healthcare Japan Corporation - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Ge Healthcare Japan Corporation

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