FDA-cleared K252084
AI4CMR v2.0
Ai4medimaging Medical Solutions S.A.
Cardiac MRI ventricular function and 2D phase-contrast flow quantification
- Modality
- MRI
- Anatomy
- Heart/Cardiovascular
- Decision
- 2026-02-11
Vendor
Ai4medimaging Medical Solutions S.A.
2 FDA-cleared listings in this directory.
Claim vendor profile FDA-cleared K220624
AI4CMR v1.0
AI4MedImaging Medical Solutions S.A.
Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone...
- Modality
- MRI
- Anatomy
- Heart, including left and right ventricles, myocardium, and cardiac chambers
- Decision
- 2022-07-22