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.

AI-Rad Companion (Pulmonary) is advanced software designed to analyze CT images of the lungs. It helps clinicians by segmenting lung regions, measuring lung volumes, identifying areas with abnormal tissue density, and detecting lung lesions including solid pulmonary nodules. This enables efficient and precise assessment of lung disease from existing CT scans, supporting better diagnosis and treatment decisions in emergency and specialty care.

FDA #
K183271
Product Code
JAK

AI Rad Companion (Engine) by Siemens Medical Solutions is a software platform designed to assist technicians and physicians in viewing, processing, and analyzing medical images from multiple modalities. It supports integration with PACS systems and allows external AI-based post-processing extensions, improving clinical image analysis and workflow.

FDA #
K183272
Product Code
LLZ

The syngo Application Software by Siemens is a versatile medical imaging software that allows clinicians to view, manipulate, and process medical images in real time. It supports diagnostic image review and various interventional procedures by providing image-guided navigation, fusion of ultrasound with fluoroscopy, and 3D visualization to improve anatomical orientation and procedural accuracy. This software helps clinicians streamline complex procedures and enhances treatment planning and control.

FDA #
K170747
Product Code
LLZ

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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