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510(k) Data Aggregation

    K Number
    K161201
    Device Name
    ClearRead CT
    Manufacturer
    RIVERAIN TECHNOLOGIES, LLC
    Date Cleared
    2016-09-09

    (134 days)

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

    RIVERAIN TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ClearRead CT™ is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest on an asymptomatic population. The ClearRead CT requires both lungs be in the field of view. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.
    Device Description
    ClearRead CT is a dedicated post-processing application that generates a secondary vessel suppressed Lung CT series with CADe marks and associated region descriptors intended to aid the radiologist in the detection of pulmonary nodules.
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