GE Healthcare Japan Corporation

8 AI-enabled medical devices from GE Healthcare Japan Corporation on FDA's AI-enabled device list, newest first. Includes filings under name variants as submitted to FDA.

DecisionNumberDeviceCompanyPanel
2026-03-23K253686True Definition DLGe Healthcare Japan CorporationRadiology
2024-04-11K233698True Enhance DLGE Healthcare Japan CorporationRadiology
2023-04-20K230807Deep Learning Image ReconstructionGE Healthcare Japan CorporationRadiology
2022-07-29K220961Deep Learning Image ReconstructionGE Healthcare Japan CorporationRadiology
2022-02-04K213938Revolution AscendGE Healthcare Japan CorporationRadiology
2021-09-17K212067Deep Learning Image ReconstructionGE Healthcare Japan CorporationRadiology
2020-11-20K203169Revolution AscendGE Healthcare Japan CorporationRadiology
2019-12-13K193170Deep Learning Image ReconstructionGE Healthcare Japan CorporationRadiology

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