FDA Radiology AI Devices

The 2430TCA with Xmaru W is a digital flat panel X-ray detector system designed for mammographic screening. It replaces traditional film or screen-based mammographic systems by capturing and digitizing high-quality breast images, assisting clinicians in breast cancer screening with enhanced image quality and reduced noise.

VIVIX-M is a series of advanced flat panel detectors designed for digital mammography. These detectors capture high-quality digital X-ray images of the breast to assist clinicians in screening and diagnosing breast conditions. The system processes the X-ray signals into detailed digital images compatible with medical imaging workflows, supporting effective and accurate mammography examinations.