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.

CINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.

FDA #
K240942
Product Code
QAS

BriefCase is an AI-powered software that helps radiologists prioritize cervical spine CT scans by flagging possible fractures. It runs alongside standard image interpretation, notifying clinicians quickly about suspected cases to enable faster patient management, but it is not used for final diagnosis. This helps improve workflow efficiency and timely attention to urgent cases.

FDA #
K190896
Product Code
QAS
Page 1 of 12 results
1

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.