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510(k) Data Aggregation

    K Number
    K043293
    Device Name
    MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U
    Manufacturer
    Date Cleared
    2004-12-17

    (18 days)

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

    ACRORAD CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mini Gamma Camera MGC500-101U and MGC500-301U are indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC500-101U and MGC500-301U may also be used intraoperatively if a protective sheath is used.
    Device Description
    The Mini Gamma Camera MGC500-101U and MGC500-301U , are nuclear medical imagers (commonly known as a scintillation or gamma camera) that are smaller, lighter and more portable than most existing gamma cameras. The MGC500-101U and MGC500-301U are intended for use in nuclear medicine procedures, including intraoperative procedures. To collect such information, it extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical. While previous gamma cameras have consisted of a sodium iodide scintillating crystal and photomultiplier tube (PMT), the design of the MGC500-101U and MGC500-301U incorporate solid-state CdTe semiconductor detectors. This allows the device to be smaller, lighter, and more portable. Both of the modified models have a new high-uniformity mode and the Model MGC500-301U has been reconfigured into a more compact design.
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    K Number
    K040587
    Device Name
    MINI GAMMA CAMERA, MODEL MGC-500
    Manufacturer
    Date Cleared
    2004-05-14

    (70 days)

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

    ACRORAD CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.
    Device Description
    The Mini Gamma Camera, MGC500, is a nuclear medical imager (commonly known as a scintillation or gamma camera) that is smaller, lighter and more portable than the existing gamma cameras. The MGC500 is intended for use in nuclear medicine procedures, including intraoperative procedures. To collect such information, it extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical. While previous gamma cameras have consisted of a sodium iodide scintillating crystal and photomultiplier tube (PMT), the design of the MGC-500 incorporates a solid-state CdTe semiconductor detector. This allows the device to be smaller, lighter, and more portable.
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