iQ-solutions
Sydney Neuroimaging Analysis Centre Pty LtdiQ-solutions is a software device designed to automatically identify, annotate, and measure specific brain structures on MRI scans. It helps clinicians by accelerating the quantification process, providing detailed volume analysis reports that support the assessment of brain anatomy and changes over time. The software improves workflow efficiency and consistency in brain MRI analysis.
Intended Use
Software medical device for automatic annotation, visualization, and quantification of segmentable brain structures from brain MRI scans, with cross-sectional and longitudinal analysis pipelines.
Technology
Uses pre-trained convolutional neural networks (CNNs) for brain structure segmentation, preprocessing components to standardize MRI input, and post-processing for report generation. Operates as standalone software integrated with clinical PACS systems to output volumetric reports and DICOM images with annotations.
Performance
Tested on in-house and public MRI datasets totaling thousands of scans from multiple vendors. Validation used manual expert annotations with high accuracy metrics (e.g., DICE scores >0.7 for segmentation). Bench testing verified performance across multiple modules with all tests passing acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/30/2023
5 months - 2
FDA Approval
12/18/2023
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