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FDA-cleared K232899

AI-Rad Companion Organs RT

Siemens Medical Solutions U.S.A.

Authorized purpose: AI-Rad Companion Organs RT VA50 automatically contours predefined CT and MR structures for qualified review and DICOM RTSTRUCT transfer into treatment planning; the added MR models were validated on Siemens scanner data.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2024-04-03
FDA-cleared K232305

AI-Rad Companion Brain MR

Siemens Medical Solutions U.S.A.

Authorized purpose: Post-processing image analysis to assist clinicians in viewing, analyzing, and evaluating MR brain images through automated segmentation, quantitative analysis, normative comparison, and report presentation.

Modality
MRI
Anatomy
Brain structures and white matter hyperintensities
Decision
2023-10-23
FDA-cleared K222360

AI-Rad Companion (Cardiovascular)

Siemens Medical Solutions U.S.A.

Authorized purpose: Adjunctive cardiovascular review for radiologists and physicians in emergency medicine, specialty care, urgent care and general practice, including heart volume, coronary calcium volume, aortic segmentation, aortic diameter measurement and threshold-based highlighting of enlarged diameters.

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2023-04-06