Medical Device Manufacturer · DE , Erlangen

Siemens Healthcare GmbH

28 submissions · 28 cleared · Since 2016
28
Total
28
Cleared
0
Denied

Siemens Healthcare GmbH — FDA 510(k) Submissions

Siemens Healthcare GmbH has submitted 28 FDA 510(k) premarket notifications since 2016, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Image Processing, Radiological, Automated Radiological Image Processing Software, System, X-ray, Tomography, Computed, Lung Computed Tomography System, Computer-aided Detection, System, Nuclear Magnetic Resonance Imaging . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
AI-Rad Companion Brain MR
K253057 · QIH Automated Radiological... · Radiology
Jan 2026 122d
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.Rise
K252838 · LNH System, Nuclear Magnetic... · Radiology
Dec 2025 105d
AI-Rad Companion Prostate MR
K252608 · LLZ System, Image Processing,... · Radiology
Sep 2025 22d
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
K250443 · LNH System, Nuclear Magnetic... · Radiology
Jun 2025 122d
syngo Dynamics (Version VA41D)
K242551 · QIH Automated Radiological... · Radiology
Apr 2025 219d
AI-Rad Companion Organs RT
K242745 · QKB Radiological Image... · Radiology
Mar 2025 197d
Prostate MR AI (VA10A)
K241770 · QDQ Radiological Computer... · Radiology
Mar 2025 258d
myAblation Guide (VB80A)
K240796 · QTZ Radiological Image... · Radiology
Aug 2024 137d
Syngo Carbon Enterprise Access (VA40A)
K240294 · LLZ System, Image Processing,... · Radiology
May 2024 112d
AI-Rad Companion (Pulmonary)
K233753 · JAK System, X-ray,... · Radiology
Mar 2024 120d
syngo Virtual Cockpit (VB10A)
K232744 · LLZ System, Image Processing,... · Radiology
Dec 2023 105d
Syngo Carbon Clinicals
K232856 · QIH Automated Radiological... · Radiology
Dec 2023 77d
syngo.CT Lung CAD (Version VD30)
K231157 · OEB Lung Computed Tomography... · Radiology
Jul 2023 86d
Syngo Carbon Space VA30A
K230561 · LLZ System, Image Processing,... · Radiology
Mar 2023 21d
syngo.via View&GO VA40A
K230196 · LLZ System, Image Processing,... · Radiology
Feb 2023 19d
syngo.via View&GO
K221501 · LLZ System, Image Processing,... · Radiology
Oct 2022 144d
AI-Rad Companion (Pulmonary)
K213713 · JAK System, X-ray,... · Radiology
Aug 2022 260d
Syngo Carbon Space VA20A
K213665 · LLZ System, Image Processing,... · Radiology
Jun 2022 211d
AI-Rad Companion Brain MR
K213706 · QIH Automated Radiological... · Radiology
Apr 2022 142d
syngo.CT Lung CAD
K203258 · OEB Lung Computed Tomography... · Radiology
Mar 2021 146d
syngo.via View&GO
K201477 · LLZ System, Image Processing,... · Radiology
Jul 2020 28d
syngo.via (Version VB40A)
K191040 · LLZ System, Image Processing,... · Radiology
May 2019 27d
syngo.via View&GO (Version VA10A)
K182208 · LLZ System, Image Processing,... · Radiology
Sep 2018 23d
syngo.plaza
K180563 · LLZ System, Image Processing,... · Radiology
Apr 2018 51d
syngo?.via protoNeo (Version VA20)
K173378 · LLZ System, Image Processing,... · Radiology
Nov 2017 21d
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