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    K Number
    K110601
    Device Name
    SENTINELLA 102
    Manufacturer
    GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
    Date Cleared
    2011-03-18

    (16 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K092471
    Device Name
    MODEL SENTINELLA 102
    Manufacturer
    GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
    Date Cleared
    2009-10-02

    (52 days)

    Product Code
    IYX
    Regulation Number
    892.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel. Sentinella 102 may be used intraoperatively if a protective sheath is used. Sentinella 102 may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
    Device Description
    Sentinella 102 is a portable gamma camera system including a small gamma camera designed to obtain images from small organs and structures labeled using radionuclides emitting gamma-rays. The Sentinella system also includes analysis and display equipment, a cart and ergonomic arm, which facilitates the equipment portability and positioning, and accessories.
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