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510(k) Data Aggregation
K Number
K192051Device Name
THINQ
Manufacturer
Date Cleared
2020-09-30
(427 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
CorticoMetrics LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
THINQ is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. Volumetric measurements may be compared to reference percentile data.
Device Description
THINQ™ is a software-only, non-interactive, medical device for quantitative imaging, accepting as input 3D T1-weighted MRI scan data of the human head. THINQ™ produces as output a quantitative neuromorphometry report in PDF format. The report contains morphometric (volume) measurements and visualizations of various structures in the brain, and compares these measures to age and gender-matched reference percentile data. The report includes images of the brain with color-coded segmentations, as well as plots showing how measurements compare to reference data. Additionally, in order to visually confirm the accuracy of the results, three segmentation overlays are created in DICOM-JPEG format; one in each anatomical plane: sagittal, coronal and axial.
The THINQ™ processing pipeline performs an atlas-based segmentation of brain structures followed by measurement of those structures and a comparison to a reference dataset. The pipeline includes automated QA checks on the input DICOM 3D T1 MRI series to ensure adherence to imaging sequence requirements, checks on the data elements generated during the processing pipeline, and usage of a classifier to filter potentially incorrect reports due to corrupted image input.
THINQ™ is packaged as a container, for deployment and operation in a high-performance computing environment within a clinical workflow.
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