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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 LVO

iSchemaView Inc.
510k5/31/2022

Rapid LVO is a software device designed to analyze CT angiography images of the head to help healthcare providers identify suspected large vessel occlusions quickly. By flagging possible cases of ICA or MCA-M1 occlusion and providing notifications with preview images, it supports faster triage and prioritization of medical images, aiding timely clinical decision-making in stroke care.

FDA #
K221248
Product Code
QAS
Modality:CTTask:TriageBody Region:NeurologicalTarget Condition:Large Vessel Occlusion

Rapid LVO

iSchemaView Inc.
510k7/9/2020

Rapid LVO is a software tool that helps hospitals and radiologists quickly identify and prioritize suspected cases of Large Vessel Occlusion (LVO) in head CT angiography images. It analyzes images using a software algorithm and provides notifications with preview images to assist clinical workflow, without replacing standard diagnostic procedures.

FDA #
K200941
Product Code
QAS
Modality:CTTask:TriageBody Region:NeurologicalTarget Condition:Large Vessel Occlusion
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