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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.

Rapid CTA 360

iSchemaView
510k7/16/2025

Rapid CTA 360 by iSchemaView is an AI software designed to assist radiologists by automatically triaging and notifying critical findings on CT angiography scans. This helps clinicians quickly identify urgent conditions and prioritize patient care effectively.

FDA #
K251151
Product Code
QAS
Modality:CTTask:TriageBody Region:Vascular

BriefCase-Triage

Aidoc Medical, Ltd.
510k5/30/2025

BriefCase-Triage by Aidoc Medical, Ltd. is an AI-powered software designed to assist radiologists by analyzing CT chest and abdomen scans and flagging cases with suspected aortic dissection. It helps medical specialists prioritize urgent cases by sending notifications and preview images, improving workflow efficiency without altering the original medical images or replacing diagnostic interpretation.

FDA #
K251406
Product Code
QAS
Modality:CTTask:TriageBody Region:VascularTarget Condition:Aortic Dissection
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