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FDA-cleared K250330

3mensio Workstation

Pie Medical Imaging BV

3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray angiography, and two- and three-dimensional ultrasound DICOM data for planning and sizing cardiovascular interventions, postoperative evaluation, coronary measurements, and calcium scoring.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart/Cardiovascular
Decision
2025-11-03