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

10
Total
10
Cleared
0
Denied

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

10 devices
1-10 of 10
Cleared Mar 23, 2026
True Definition DL
K253686 · JAK
Radiology · 122d
Cleared Apr 11, 2024
True Enhance DL
K233698 · JAK
Radiology · 146d
Cleared Apr 20, 2023
Deep Learning Image Reconstruction
K230807 · JAK
Radiology · 28d
Cleared Jul 29, 2022
Deep Learning Image Reconstruction
K220961 · JAK
Radiology · 119d
Cleared Feb 04, 2022
Revolution Ascend
K213938 · JAK
Radiology · 50d
Cleared Sep 17, 2021
Deep Learning Image Reconstruction
K212067 · JAK
Radiology · 77d
Cleared Nov 20, 2020
Revolution Ascend
K203169 · JAK
Radiology · 28d
Cleared Dec 13, 2019
Deep Learning Image Reconstruction
K193170 · JAK
Radiology · 28d
Cleared Jul 10, 2015
SIGNA Pioneer
K143345 · LNH
Radiology · 231d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327 · LNH
Radiology · 322d
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