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

CINA-VCF is an AI-powered software device designed to analyze chest and abdominal CT scans in patients aged 50 and above to identify suspected vertebral compression fractures. It operates alongside standard imaging workflows to prioritize and notify clinicians of potentially positive cases, helping improve triage speed and efficiency without altering original images or serving as a diagnostic tool itself.

FDA #
K240612
Product Code
QFM
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