Siemens Healthcare GmbH

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

DecisionNumberDeviceCompanyPanel
2026-04-10K252548AI-Rad Companion Organs RTSiemens Healthcare GmbHRadiology
2026-04-10K253689syngo Dynamics (VA41F)Siemens Healthcare GmbHRadiology
2026-01-22K253057AI-Rad Companion Brain MRSiemens Healthcare GmbHRadiology
2025-12-19K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseSiemens Healthcare GmbHRadiology
2025-06-16K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbHRadiology
2025-04-03K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbHRadiology
2025-03-27K242745AI-Rad Companion Organs RTSiemens Healthcare GmbHRadiology
2025-03-05K241770Prostate MR AI (VA10A)Siemens Healthcare GmbHRadiology
2024-05-23K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbHRadiology
2024-03-21K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbHRadiology
2023-12-01K232856Syngo Carbon ClinicalsSiemens Healthcare GmbHRadiology
2023-07-19K231157syngo.CT Lung CAD (Version VD30)Siemens Healthcare GmbHRadiology
2022-08-11K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmBhRadiology
2022-04-15K213706AI-Rad Companion Brain MRSiemens Healthcare GmBhRadiology
2021-03-31K203258syngo.CT Lung CADSiemens Healthcare GmbHRadiology

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