AIRAscore
AIRAmed GmbHAIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.
Intended Use
AIRAscore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
Technology
AIRAscore is a software as a medical device (SaMD) running on internal servers as a Software as a Service (SaaS). It uses DICOM compliant input of T1-weighted and optionally FLAIR MR images. Segmentation is performed by a supervised voxel classification using Convolutional Neural Networks. Output includes volumetric reports and annotated DICOM images. The segmentation models remain static during the software version lifetime.
Performance
Performance testing involved software verification with unit, integration, and end-to-end testing per IEC 62304. Validation showed AIRAscore performs well across patient populations and scanner manufacturers. Results meet software requirements and comply with relevant standards including ISO 14971 and IEC 62304.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/11/2022
10 months - 2
FDA Approval
8/25/2023
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