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.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to help hospital specialists prioritize and triage cases showing possible incidental Pulmonary Embolism. It provides notifications with compressed preview images for early attention but does not replace standard diagnostic review, working alongside existing workflows to speed up urgent case identification.

FDA #
K213886
Product Code
QAS

CINA CHEST is an AI-powered software that analyzes chest and thoraco-abdominal CT angiography scans to detect signs of pulmonary embolism and aortic dissection. It helps radiologists prioritize cases by flagging suspected positive findings through notifications, thereby improving workflow efficiency and timely patient care. The tool works alongside standard image interpretation without altering original images and is not intended for diagnosis alone but as an aid for faster triage.

FDA #
K210237
Product Code
QAS

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to detect incidental pulmonary embolism. The software notifies radiologists of suspected positive cases via a desktop application, helping prioritize urgent cases for faster review without replacing the standard diagnostic process. It supports workflow improvements by flagging cases early, potentially saving hours in time to examination.

FDA #
K201020
Product Code
QAS
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