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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.

Quantib Brain 1

QUANTIB BV
510k6/17/2016

Quantib Brain 1 is an AI-powered software tool that automatically labels and measures the volumes of brain structures from MRI scans. It helps radiologists by providing quantitative data and visualization of brain tissue and white matter abnormalities to support diagnosis and reporting.

FDA #
K153351
Product Code
LLZ
Modality:MRITask:SegmentationBody Region:Neurological

IB NEURO, VERSION 1.0

IMAGING BIOMETRICS, LLC
510k5/15/2008

IB Neuro v1.0 is software that processes MRI data to create maps showing blood flow and volume in the brain. These maps help doctors evaluate brain perfusion and may assist in clinical decision-making. The software integrates easily with existing MRI systems and PACS to streamline the workflow for clinicians.

FDA #
K080762
Product Code
LNH
Modality:MRITask:Image SynthesisBody Region:Neurological
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