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-Triage is an AI-powered software designed to assist hospital networks and trained radiologists in identifying suspected pulmonary embolism cases from CT pulmonary angiography (CTPA) images. The software analyzes images in parallel with standard interpretation, flags potential positive findings, and notifies clinicians with compressed preview images for triage purposes, helping prioritize urgent cases and reduce turnaround times without replacing standard diagnostic workflows.

FDA #
K241727
Product Code
QAS

CINA-iPE is an AI-powered software that analyzes contrast-enhanced CT scans (not dedicated CTPA) to help detect incidental pulmonary embolisms. It flags suspected positive cases in real-time to assist radiologists in prioritizing patients and improving workflow efficiency. It operates alongside standard care without altering original images and provides informative preview notifications but does not replace diagnostic review.

FDA #
K233968
Product Code
QAS

BriefCase-Triage by Aidoc Medical is an AI-powered software that analyzes CT pulmonary angiography images to detect suspected cases of Central Pulmonary Embolism. It provides notifications and low-quality preview images to assist trained clinicians in prioritizing urgent cases, helping speed up patient care without replacing the standard diagnostic process.

FDA #
K232751
Product Code
QAS

BriefCase by Aidoc Medical is an AI-powered software that analyzes CTPA images to detect suspected Pulmonary Embolism cases and notifies clinicians via a desktop application to prioritize these potentially critical cases. It works alongside the standard image interpretation process, helping healthcare professionals triage faster and improve patient care without altering original medical images.

FDA #
K222277
Product Code
QAS

Rapid PE Triage and Notification (PETN) is an AI-powered software that analyzes CT pulmonary angiography scans to detect and notify clinicians of suspected central pulmonary embolism cases. It assists hospital networks and clinicians by prioritizing patient workflows and flagging positive findings, helping improve timely diagnosis and treatment without altering original medical images.

FDA #
K220499
Product Code
QAS

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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