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FDA-cleared K241922

Myomics

Phantomics Inc.

Authorized purpose: Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including heart and adjacent-vessel measurements; semi-automated machine-learning workflows are intended for adults and contribute to comprehensive diagnostic decision-making.

Modality
MRI
Anatomy
Heart/Cardiovascular
Decision
2025-02-28