QView Medical, Inc. radiology AI products

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FDA-approved P150043

QVCAD System

QView Medical, Inc.

Authorized purpose: The QVCAD System is indicated as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System, for screening mammography BI-RADS Assessment Category 1 or 2 and BI-RADS composition or density c or d, to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators are not intended for diagnostic characterization of suspicious findings.

Modality: Ultrasound
Anatomy: Female breasts; mammography-occult lesions in non-suspicious regions
Decision: 2016-11-09