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510(k) Data Aggregation

    K Number
    K173145
    Device Name
    CereMetrix Silver
    Manufacturer
    Date Cleared
    2018-02-28

    (152 days)

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

    CereMetrix Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CereMetrix Silver software is used by trained medical professionals as a tool to aid in evaluation and information management of digital medical image modalities include SPECT, PET, MRI and CT as supported by ACR/NEMA DICOM 3.0. CereMetrix Silver assists in the following indications: · Receive, transmit, store, retrieve, display, print, and process brain images and DICOM objects derived from radiological diagnostic systems, and processing workstations, among others. · Create, display and print reports from medical images. · Registration and review of brain images for diagnosis, treatment evaluation, and treatment planning. · Localization and definition of objects and the differentiation between hyper or hypo perfused tissue, as compared to a composite average, in medical images. · Creation of clusters for applications including quantitative analysis and archiving clusters for patient follow-up and management. · CereMetrix Silver is capable of processing and displaying the brain image data in traditional formats, as well as pseudo three-dimensional renderings. · CereMetrix Silver provides manual and automatic report creation plus the ability to view these reports remotely. · CereMetrix Silver allows for quantitative and statistical analysis of SPECT brain scans by comparing to a composite average. When used for diagnostic purposes, the mobile web client is not intended to replace a fill workstation and should only be used when there is no access to a workstation. The software is not to be used for computer aided diagnostic purposes, including mammography CAD.
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