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510(k) Data Aggregation

    K Number
    K201807
    Device Name
    ANCORIS
    Manufacturer
    Date Cleared
    2020-08-27

    (57 days)

    Product Code
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MiEGmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 'ANCORIS' PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.
    Device Description
    The proposed device 'ANCORIS' is a PET system providing volume measurements of metabolic and physiologic processes. It is the same as the legally market device, name 'ECAT ACCEL PET scanner', K002584, from CTI PET Systems (now Siemens Medical), combined with the legally market device, name 'ECAT Scintron PET', K130269 from MiE GmbH. It is designed to close the economical gap between the demand and availability of stand-alone PET scanner. 'ANCORIS' PET Scanner is designed to perform acquisitions, image The reconstruction, processing, viewing and analysis of data. It uses the same technology and has the same performance as well as indications for use as the leqally market devices. The system includes the gantry with transmission scan capability, the currently market integrated workstation 'ECAT Scintron PET' (K130269) and the new designed PHS. The system is available as a three detector-ring system with a 16.2cm field of view same as used in currently marketed device ECAT ACCEL PET Scanner (K002584).
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