FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The RadiForce RX570 and RX570-AR are high-resolution color LCD monitors designed for viewing medical images, including mammography and digital breast tomosynthesis. These monitors provide calibrated display modes ensuring consistent, high-quality images for radiologists, aiding in accurate image review, analysis, and diagnosis. The devices come with quality control software to support reliable monitor calibration and performance verification.

FDA #
K243221
Product Code
PGY

The LCD Monitors C310S, G310S, C316S, G316S, and C616W by Shenzhen Beacon Display Technology Co.,Ltd. are high-resolution, calibrated diagnostic displays specifically designed for radiology. These monitors support the viewing and analysis of digital images such as X-rays and MRIs, helping clinicians review and diagnose patient conditions accurately. They incorporate advanced LED backlighting, brightness stabilization, and anti-glare screens to ensure image clarity and consistency, crucial for precise medical evaluation.

FDA #
K243031
Product Code
PGY
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