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 ICH

iSchemaView Incorporated

510k3/31/2020

Rapid ICH is an AI-powered clinical software tool designed to help hospital radiology workflows by automatically analyzing non-contrast head CT scans to detect suspected intracranial hemorrhage. It provides alerts and compressed preview images to clinicians through PACS, email, and a mobile app to prioritize urgent cases and aid timely diagnosis and treatment decisions.

FDA #

K193087

Product Code

QAS

Panel

Radiology

Modality:CT Task:Triage Body Region:Neurological Target Condition:Intracranial Hemorrhage

iSchemaView RAPID

iSchemaView, Inc.

510k12/27/2018

iSchemaView RAPID is a software package that helps medical professionals view and analyze CT and MRI images, particularly to evaluate stroke patients for endovascular thrombectomy. It provides advanced image processing for perfusion, diffusion, and angiography to aid clinical decision-making.

FDA #

K182130

Product Code

LLZ

Panel

Radiology

Modality:CT Task:Classification Body Region:Neurological Target Condition:Stroke

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