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510(k) Data Aggregation

    K Number
    K162052
    Device Name
    Sentinella 102, Sentinella 102 Horus
    Manufacturer
    GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
    Date Cleared
    2016-08-18

    (24 days)

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

    GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) 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 (models Sentinella 102 and Sentinella 102 Horus) may be used intraoperatively if a protective sheath is used. Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
    Device Description
    Sentinella 102 is a currently marketed portable gamma camera system which includes 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. Due to the difficulty which may involve indentifying the physical location in the body of the patient of the structures observed in the gammagraphy, the model Sentinella 102 Horus incorporates an optical camera that registers the same area that it is being observed by the gamma camera. Both images are coregistered and shown in real time. During this process, the gammagraphy is not reprocessed or modified in any way, so remains unaltered at the end of the process.
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    K Number
    K143156
    Device Name
    Sentinella 102; Sentinella 102 Horus
    Manufacturer
    GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
    Date Cleared
    2014-11-18

    (15 days)

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

    GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sentinella 102 (Models Sentinella 102 Horus) 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 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used. Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
    Device Description
    Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection.
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    K Number
    K140996
    Device Name
    MAMMI
    Manufacturer
    GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-
    Date Cleared
    2014-06-11

    (55 days)

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

    GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION-

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAMMI (Models: FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.
    Device Description
    Not Found
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