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Siemens Healthcare GmbH FDA Approvals

0 new drug approvals and 23 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
myAblation Guide (VC10A)510(k)Jun 16, 2026Radiology
syngo Dynamics (VA41F)510(k)Apr 10, 2026Radiology
AI-Rad Companion Organs RT510(k)Apr 10, 2026Radiology
AI-Rad Companion Brain MR510(k)Jan 22, 2026Radiology
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise510(k)Dec 19, 2025Radiology
AI-Rad Companion Prostate MR510(k)Sep 9, 2025Radiology
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile510(k)Jun 16, 2025Radiology
syngo Dynamics (Version VA41D)510(k)Apr 3, 2025Radiology
AI-Rad Companion Organs RT510(k)Mar 27, 2025Radiology
Prostate MR AI (VA10A)510(k)Mar 5, 2025Radiology
myAblation Guide (VB80A)510(k)Aug 6, 2024Radiology
Syngo Carbon Enterprise Access (VA40A)510(k)May 23, 2024Radiology
AI-Rad Companion (Pulmonary)510(k)Mar 21, 2024Radiology
syngo Virtual Cockpit (VB10A)510(k)Dec 21, 2023Radiology
Syngo Carbon Clinicals510(k)Dec 1, 2023Radiology
syngo.CT Lung CAD (Version VD30)510(k)Jul 19, 2023Radiology
Syngo Carbon Space VA30A510(k)Mar 21, 2023Radiology
syngo.via View&GO VA40A510(k)Feb 13, 2023Radiology
syngo.via View&GO510(k)Oct 14, 2022Radiology
AI-Rad Companion (Pulmonary)510(k)Aug 11, 2022Radiology
Syngo Carbon Space VA20A510(k)Jun 21, 2022Radiology
AI-Rad Companion Brain MR510(k)Apr 15, 2022Radiology
syngo.CT Lung CAD510(k)Mar 31, 2021Radiology

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