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FDA-approved P200003

Imagio Breast Imaging System

Seno Medical Instruments, Inc.

Imagio combines ultrasound and optoacoustic imaging to evaluate palpable or non-palpable breast abnormalities in adults referred for diagnostic workup. Ultrasound can assign BI-RADS, and optoacoustic features can assist assessment of BI-RADS 3-5 masses based on vascularity and blood oxygen saturation.

Modality
Optoacoustic Imaging
Anatomy
Breast
Decision
2021-01-11