GE Healthcare

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

DecisionNumberDeviceCompanyPanel
2025-11-21P130020/S005Senographe Pristina 3DGE HealthcareRadiology
2025-04-01K242925MR Contour DLGE HealthCareRadiology
2023-04-27K223212Precision DLGE HealthcareRadiology
2023-03-01K221680Xeleris V Processing and Review SystemGE HealthcareRadiology
2022-02-17K213689Voluson P6, Voluson P8GE HealthcareRadiology
2022-01-13K213642Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 ExpertGE HealthcareRadiology
2020-09-25K201103Xeleris V Processing and Review SystemsGE HealthcareRadiology
2018-12-14K182419Centricity Universal ViewerGE HealthcareRadiology

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