FDA-cleared K252084
AI4CMR v2.0
Ai4medimaging Medical Solutions S.A.
Authorized purpose: 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 submission entries in this directory. This is not a count of distinct commercial offers.
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FDA-cleared K220624
AI4CMR v1.0
AI4MedImaging Medical Solutions S.A.
Authorized purpose: 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 clinical decision-making.
- Modality
- MRI
- Anatomy
- Heart, including left and right ventricles, myocardium, and cardiac chambers
- Decision
- 2022-07-22