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510(k) Data Aggregation

    K Number
    K223180
    Device Name
    AIRAscore
    Manufacturer
    Date Cleared
    2023-08-25

    (318 days)

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

    AIRAmed GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
    Device Description
    AIRAscore is a software that offers automatic, fast and reliable segmentation of brain volumes into gray matter, white matter, cerebrospinal fluid and, if present, white matter lesions with an additional classification of tissue anatomy. The AIRAscore software comprises two functions, referred to as "AIRAscore structure" and "AIRAscore MS". The report created using the AIRAscore structure function contains the volume evaluation for each seqmented anatomical area with the raw value, the relative value with respect to the total intracranial volume, and the percentile for the patient compared to a reference set. It furthermore provides a quick overview of potential segment size differences based on the reference set comparison. If the AIRAscore MS report is requested, it is provided with additional information about the number and the volume of white matter lesions and their categorization (i.e., juxtacortical, periventricular or infratentorial). For analysis with AIRAscore, incoming MRI data need to comply with the DICOM standard and are checked to fulfill the technical requirements. After successful verification, segmentation is performed using specialized neuronal networks that remain static during the lifetime of a software version. The results are then corrected for head size and compared to an age- and sex adjusted reference collective including a statistical classification. A report is generated and transmitted via a DICOM storage SCU (sender) to a defined DICOM storage SCP (usually the picture archive of the referring physician) using the DICOM format.
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