# Ge Healthcare Japan Corporation

- Location (FDA's records): Hino, JP
- FDA decisions: 10 (2011–2026): 10 510(k) clearances
- Product codes: JAK (8), LNH (2)
- 510(k) review time since 2016: median 64 days, against 135 for FDA's reviews in the same codes and years (7 of 8 faster)
- Predicates its devices cite: 11 (3 its own); citations of its devices by later devices: 10 (3 its own)
- Recalls linked to its devices: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- GE Medical Systems: 7 (https://510kreport.com/company/ge-medical-systems)
- Ge Hangwei Medical Systems Co., Ltd.: 1 (https://510kreport.com/company/ge-hangwei-medical-systems)

## Firms that cite its devices most
- GE Healthcare: 2 (https://510kreport.com/company/ge-healthcare)
- GE Medical Systems: 2 (https://510kreport.com/company/ge-medical-systems)
- Ge Hangwei Medical Systems Co., Ltd.: 2 (https://510kreport.com/company/ge-hangwei-medical-systems)
- Ge Healthcare Coils (Usa Instruments, Inc.): 1 (https://510kreport.com/company/ge-healthcare-coils-usa-instruments)

## Its most-cited devices
- K103327: Discovery MR750W 3.0T (2011), cited by 3
- K143345: SIGNA Pioneer (2015), cited by 3
- K213938: Revolution Ascend (2022), cited by 2
- K203169: Revolution Ascend (2020), cited by 1
- K193170: Deep Learning Image Reconstruction (2019), cited by 1

## Recent decisions
- K253686: True Definition DL (Mar 23, 2026)
- K233698: True Enhance DL (Apr 11, 2024)
- K230807: Deep Learning Image Reconstruction (Apr 20, 2023)
- K220961: Deep Learning Image Reconstruction (Jul 29, 2022)
- K213938: Revolution Ascend (Feb 4, 2022)
- K212067: Deep Learning Image Reconstruction (Sep 17, 2021)
- K203169: Revolution Ascend (Nov 20, 2020)
- K193170: Deep Learning Image Reconstruction (Dec 13, 2019)

Source page: https://510kreport.com/company/ge-healthcare-japan