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510(k) Data Aggregation

    K Number
    K231929
    Device Name
    iQ-solutions
    Date Cleared
    2023-12-18

    (171 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sydney Neuroimaging Analysis Centre Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. iQ-solutions™ consists of both cross-sectional and longitudinal analysis pipelines. - . The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point. - . The longitudinal pipeline is intended to conduct volume change analysis on a single patient's MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points. The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.
    Device Description
    iQ-solutions™ is a standalone software device that processes brain MRI scans to outline and quantify the brain structures described in the intended use. The iQ-solutions™ software interacts with the user's picture archiving and communication system (PACS) to receive scans and returns the results to the same destination or other user-specified radiology software system or database. iQ-solutions™ analysis module consists of pre-trained convolutional neural networks (CNN) that have been verified and validated to segment the specific brain structures and create binary masks accordingly using the incoming head MRI scans. Each convolutional neural network is coupled with a pre-processing component that transforms the MRI scans to the standard position and contrast; and a post-processing component that prepares for the output annotations, statistical calculation, and the input of the next analysis component in either analysis pipeline. iQ-solutions™ operates together with a medical image routing software or an integration platform that can connect with iQ-solutions™ and a PACS system that can fulfill the requirements of iQsolutions™. MRI scans are sent to iQ-solutions™ by means of transmission functions within the user's PACS system. Upon completion of processing, iQ-solutions™ returns results to the user's PACS or other userspecified radiology software system or database. The results from iQ-solutions™ are not intended to be used as a diagnostic tool, and the interpretation of measurements contained in the iQ-solutions™ report remains entirely the responsibility of the qualified radiologists or physicians managing the individual patient's care.
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