FDA Radiology AI Devices

The Imagio Breast Imaging System is a diagnostic tool that combines optoacoustic imaging and ultrasound to provide detailed structural and functional information about breast abnormalities. It uses AI-based software to help healthcare providers better classify breast masses, thereby improving diagnosis. The device is designed to assist, not replace, mammographic screening or biopsy.

QVCAD System by QView Medical, Inc. is a specialized AI software that aids radiologists in detecting breast lesions in 3D automated breast ultrasound images. It uses advanced image pattern recognition and neural networks to highlight suspicious areas that may indicate breast cancer, helping clinicians improve detection accuracy and reduce interpretation time during breast screening, especially for women with dense breasts.