Question 1

What types of medical devices does Siemens Healthcare GmbH develop and provide?

Accepted Answer

Siemens Healthcare GmbH specializes in software and imaging solutions primarily for computed tomography (CT) systems. Their portfolio includes automated detection and quantification tools for conditions like large vessel occlusion (LVO), coronary artery disease, and brain perfusion. They also offer AI-driven diagnostic aids for chest X-rays, perfusion analysis, and a mobile imaging system for point-of-care use. Software updates for existing CT systems are also part of their offerings.

Question 2

Where is Siemens Healthcare GmbH based, and what regulatory frameworks does it operate under?

Accepted Answer

Siemens Healthcare GmbH is headquartered in Germany. The company operates within the regulatory frameworks of both the European Union and the United States, ensuring compliance with relevant medical device regulations in these regions.

Question 3

Which regulatory registries list Siemens Healthcare GmbH’s medical devices?

Accepted Answer

Siemens Healthcare GmbH’s devices are listed in the EUDAMED database under the European Union’s regulatory framework and in the FDA’s 510(k) registry for the United States. These registries document the classification and compliance status of individual devices, not the company itself.

Question 4

How are Siemens Healthcare GmbH’s medical devices classified under EU regulations?

Accepted Answer

Under the EU Medical Device Regulations, Siemens Healthcare GmbH’s devices fall into Class II, Class IIa, and Class IIb categories. This classification is determined by factors like the risk associated with the device’s intended use, such as diagnostic imaging software or AI-assisted tools, which require higher scrutiny due to their potential impact on patient management and outcomes.

Question 5

What distinguishes Siemens Healthcare GmbH’s imaging solutions from other providers?

Accepted Answer

Siemens Healthcare GmbH’s imaging solutions are distinguished by their integration of advanced software and AI-driven tools into CT systems. These tools automate critical diagnostic processes, such as detecting and quantifying conditions like LVO or brain perfusion, which can significantly assist clinicians in faster, more accurate decision-making. Their focus on both hardware and software innovations—including mobile and point-of-care systems—sets them apart in the medtech space.

Device	Model / Reference	Registries	Class	Status
NAEOTOM Alpha Combination	11501073	EUDAMED	Class IIb	Active
syngo.CT Extended Functionality	11546317	EUDAMED	Class IIa	Active
syngo.CT ASPECTS	11546421	EUDAMED	Class IIa	Active
syngo.via RT Image Suite	11664618	EUDAMED	Class IIb	Active
syngo.CT LVO Detection	11549533	EUDAMED	Class IIa	Active
syngo.CT Extended Functionality	11664817	EUDAMED	Class IIa	Active
syngo.CT Liver Analysis	11546314	EUDAMED	Class IIa	Active
syngo.MR Application	11823214	EUDAMED	Class IIb	Active
YSIO X.pree VA20-SW-Update	11688596	EUDAMED	Class IIb	Active
AI-Rad Companion Chest X-ray	11823189	EUDAMED	Class IIb	Active
AI-Rad Companion Prostate MR	11666038	EUDAMED	Class IIb	Active
AI-Rad Companion Prostate MR	11582981	EUDAMED	Class IIb	Active
syngo.CT LVO Detection	11664841	EUDAMED	Class IIa	Active
syngo.CT CaScoring	11546402	EUDAMED	Class IIa	Active
syngo.CT Cardiac Function	11546305	EUDAMED	Class IIa	Active
syngo.CT Vascular Analysis	11546304	EUDAMED	Class IIa	Active
AI-Rad Companion Chest X-ray	11830637	EUDAMED	Class IIb	Active
syngo.CT Neuro Perfusion	11546309	EUDAMED	Class IIa	Active
syngo.CT Coronary Cockpit	11664855	EUDAMED	Class IIa	Active
syngo.CT Brain Quantification	11664825	EUDAMED	Class IIa	Active
MOBILETT Impact	11647500	EUDAMED	Class IIb	Active
syngo.CT Body Perfusion	11546311	EUDAMED	Class IIa	Active
syngo.CT ASPECTS	11546332	EUDAMED	Class IIa	Active
syngo.CT ASPECTS	11664821	EUDAMED	Class IIa	Active
syngo.CT Brain Quantification	11664625	EUDAMED	Class IIa	Active
syngo.CT Vessel Hyperdensities	11664842	EUDAMED	Class IIa	Active
AI-Rad Companion Chest CT	11830632	EUDAMED	Class IIb	Active
syngo.CT Pulmo3D	11546308	EUDAMED	Class IIa	Active
ARTIS pheno	10849000	EUDAMEDFDA UDI	Class IIb	Active
syngo Dynamics Version VA30	K171053	FDA 510(k)	Class II	Active
MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	K250443	FDA 510(k)	Class II	Active
AI-Rad Companion (Pulmonary)	K213713	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
syngo.plaza	K180563	FDA 510(k)	Class II	Active
syngo Dynamics (Version VA41D)	K242551	FDA 510(k)	Class II	Active
myAblation Guide (VB80A)	K240796	EUDAMEDFDA 510(k)	Class II	Active
syngo®.via protoNeo (Version VA20)	K173378	FDA 510(k)	Class II	Active
Syngo Carbon Enterprise Access (VA40A)	K240294	FDA 510(k)	Class II	Active
Syngo Carbon Space VA30A	K230561	FDA 510(k)	Class II	Active
syngo®.via protoNeo (Version VA10A)	K161685	FDA 510(k)	Class II	Active
syngo Virtual Cockpit (VB10A)	K232744	EUDAMEDFDA 510(k)FDA UDI	Class II	Active
syngo.CT Lung CAD (Version VD30)	K231157	FDA 510(k)	Class II	Active
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	FDA 510(k)	Class II	Active
syngo.CT Cardiac Planning	K170221	EUDAMEDFDA 510(k)	Class II	Active
syngo.CT Lung CAD	K203258	FDA 510(k)	Class II	Active
syngo.via (Version VB40A)	K191040	FDA 510(k)	Class II	Active
Prostate MR AI (VA10A)	K241770	FDA 510(k)	Class II	Active
syngo.via View&GO VA40A	K230196	FDA 510(k)	Class II	Active
AI-Rad Companion Prostate MR	K252608	FDA 510(k)	Class II	Active
syngo Dynamics (VA41F)	K253689	FDA 510(k)	Class II	Active
syngo.via View&GO (Version VA10A)	K182208	FDA 510(k)	Class II	Active

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