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510(k) Data Aggregation

    K Number
    K171261
    Device Name
    ScannerSide DoseCheck
    Manufacturer
    Right Dose Inc.
    Date Cleared
    2017-08-18

    (109 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Right Dose Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Scannerside Dose check is intended for providing Computed Tomographic (CT) Dose Check feature to CT X-ray systems. The Scannerside Dose Check is specifically indicated for providing the Computed Tomography Dose Check feature with notifies and alerts the CT equipment operators, prior to a scan, if the estimated dose is above a predefined threshold. This device is intended for CT scanners not equipped with this functionality. The device is indicated for use by professional personnel.
    Device Description
    Not Found
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