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510(k) Data Aggregation

    K Number
    K110384
    Device Name
    DILON 6800 ACELLA (ACELLA)
    Manufacturer
    DILON TECHNOLOGIES, INC.
    Date Cleared
    2011-05-03

    (82 days)

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

    DILON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dilon 6800 Acella Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel.
    Device Description
    The Dilon 6800 Acella (Acella) is a modification to the Dilon 2000 (now known as the Dilon 6800), a high resolution, small field of view, portable gamma camera designed for general use in imaging radio pharmaceuticals. The Acella has a larger field-of-view than the Dilon 6800 and replaces photomultiplier tubes with photodiodes. Both technologies convert visible light photons generated by scintillation crystals into electronic signals.
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    K Number
    K984466
    Device Name
    DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
    Manufacturer
    DILON TECHNOLOGIES, INC.
    Date Cleared
    1999-03-16

    (90 days)

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

    DILON TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dilon 2000 Digital Gamma Camera is intended to be used to measure and image the distribution of selected single photon emitting radioisotopes in the human body. The resulting images are intended to be reviewed by qualified medical personnel. To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). A. Planar Imaging Energy Range (keV): 100 to 200
    Device Description
    The Dilon 2000 is a high resolution, small field of view, portable gamma camera designed for general use in imaging radio pharmaceuticals. The primary components of the Dilon 2000 are: Detector Head: contains a two dimensional array of scintillation crystals, an array of position sensitive photomultiplier tubes and signal amplification and discrimination electronics. Gantry Arm: safely supports the detector as positioned by the technologist operating the camera. Counter balancing is provided to hold the detector in its last position. Mobile Cabinet: Contains data acquisition electronics, image development computer and Segami Pegasus™ imaging software. The cabinet also contains power filtering, isolation and a high voltage power supply.
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