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510(k) Data Aggregation

    K Number
    K131625
    Device Name
    ANYSCAN-S SPECT IMAGING SYSTEM
    Manufacturer
    ABSOLUTE IMAGING SOLUTIONS
    Date Cleared
    2013-10-03

    (121 days)

    Product Code
    KPS
    Regulation Number
    892.1200
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    Applicant Name (Manufacturer) :

    ABSOLUTE IMAGING SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging and tomographic imaging.
    Device Description
    The AnyScan-S is a Single- or Dual-Detector Gamma Camera System that rne Anyolanar static, dynamic as well as SPECT and whole body imaging applications with high patient throughput requirements.
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