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-Quantification is an AI-powered software that analyzes CT scans of the abdominal aorta to measure its maximum diameter. It helps trained medical specialists by providing preliminary diameter measurements to assist with evaluating normal and aneurysmal abdominal aortas, improving the efficiency of radiological assessments. The software is cloud-based, processes images from DICOM format, and integrates output with PACS for clinician review.

FDA #
K241112
Product Code
QIH

BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.

FDA #
K232083
Product Code
QIH

BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.

FDA #
K230534
Product Code
QIH
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