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 DR 800 with MUSICA Dynamic by Agfa HealthCare is an advanced fluoroscopic X-ray system designed for dynamic imaging of various body parts, such as gastrointestinal and urogenital tract examinations and angiography. It replaces traditional image intensifier technology with flat-panel digital detectors and incorporates MUSICA Dynamic software for enhanced image processing, improving image quality and aiding clinicians in accurate diagnosis while supporting pediatric and adult imaging needs.

FDA #
K180589
Product Code
JAA

YSIO MAX is a modular stationary X-ray imaging system designed for hospitals and clinics. It enables full-body radiographic and tomographic exposures and supports various patient positions. The system includes integrated and portable digital detectors that convert X-rays into diagnostic electronic images. It helps clinicians by offering efficient positioning and image processing, including optional AI-based soft tissue enhancement for chest X-rays, facilitating more accurate and timely diagnosis.

FDA #
K133259
Product Code
KPR
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