Siemens Healthcare GmbH radiology AI products

FDA-cleared K252548

AI-Rad Companion Organs RT

Siemens Healthcare GmbH

AI-Rad Companion Organs RT VA70 automatically contours predefined structures, including known diagnosed brain metastases, on DICOM CT and MR images for radiation therapy planning;...

Modality: Radiotherapy Planning Imaging
Anatomy: Head/neck, thorax, abdomen, pelvis; MR brain and male pelvis
Decision: 2026-04-10

Radiotherapy planning

FDA-cleared K253689

syngo Dynamics (VA41F)

Siemens Healthcare GmbH

syngo Dynamics VA41F is a vendor-agnostic cardiology image and information-management system that supports multimodality review, diagnosis, and patient management for the labeled...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Cardiac; vascular; and maternal-fetal medicine anatomy
Decision: 2026-04-10

Cardiac imaging

FDA-cleared K253057

AI-Rad Companion Brain MR

Siemens Healthcare GmbH

Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.

Modality: MRI
Anatomy: Brain
Decision: 2026-01-22

Quantification and segmentation Neuro MRI

FDA-cleared K252838

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

Siemens Healthcare GmbH

The listed MAGNETOM 1.5T and 3T MRI systems produce cross-sectional images, spectroscopic images or spectra, and derived physical parameters of the head, body, and extremities for...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-12-19

MRI workflow

FDA-cleared K250443

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

Siemens Healthcare GmbH

MAGNETOM Avanto Fit, Skyra Fit, Sola Fit, and Viato.Mobile with syngo MR XA70A produce diagnostic MR images, spectra, and derived physical parameters and add model-specific Deep...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-06-16

MRI workflow

FDA-cleared K242551

syngo Dynamics (Version VA41D)

Siemens Healthcare GmbH

syngo Dynamics VA41D is a multimodality, vendor-agnostic cardiology image and information system for management, processing, review, post-processing, and quantification of cardiac...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Cardiac, vascular, obstetric, and fetal anatomy represented in multimodality studies
Decision: 2025-04-03

Cardiac imaging Quantification and segmentation

FDA-cleared K242745

AI-Rad Companion Organs RT

Siemens Healthcare GmbH

AI-Rad Companion Organs RT VA60 automatically contours predefined CT and MR structures for qualified review and DICOM RTSTRUCT transfer into treatment planning; this release added...

Modality: Radiotherapy Planning Imaging
Anatomy: Multi-region
Decision: 2025-03-27

Radiotherapy planning

FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Prostate MR AI (VA10A) is a plug-in CADe/CADx aid for radiologists interpreting prostate MRI in adult men aged 40 years or older with suspected prostate cancer and no prior...

Modality: MRI
Anatomy: Prostate
Decision: 2025-03-05

Prostate imaging Detection and CADe

FDA-cleared K240294

Syngo Carbon Enterprise Access (VA40A)

Siemens Healthcare GmbH

Syngo Carbon Enterprise Access is indicated for display and rendering of medical data within healthcare institutions. The FDA summary describes an enterprise web application for...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Medical data and clinical images within healthcare institutions
Decision: 2024-05-23

Radiological images; modality varies or is not specified in FDA list workflow

FDA-cleared K233753

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmbH

AI-Rad Companion Pulmonary is image-processing software that provides quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and...

Modality: CT/CTA
Anatomy: Adult lungs, lung lobes, pulmonary parenchyma, and solid or sub-solid lung nodules
Decision: 2024-03-21

Lung nodule detection Detection and CADe Quantification and segmentation

FDA-cleared K232856

Syngo Carbon Clinicals

Siemens Healthcare GmbH

Syngo Carbon Clinicals provides advanced visualization tools to prepare and process medical images acquired by modalities such as CT and MR for evaluation, manipulation,...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Anatomy represented in CT, MR, and other supported clinical images, including lung lesion workflows
Decision: 2023-12-01

Quantification and segmentation

FDA-cleared K231157

syngo.CT Lung CAD (Version VD30)

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2023-07-19

Detection and CADe Chest CT

FDA-cleared K213713

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmBh

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2022-08-11

Chest CT

FDA-cleared K213706

AI-Rad Companion Brain MR

Siemens Healthcare GmBh

AI-Rad Companion Brain MR VA40 post-processes head MR images to segment and quantify brain structures and white-matter hyperintensities, compare normalized values with healthy...

Modality: MRI
Anatomy: Brain
Decision: 2022-04-15

Quantification and segmentation Neuro MRI

FDA-cleared K203258

syngo.CT Lung CAD

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2021-03-31

Detection and CADe Chest CT