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510(k) Data Aggregation

    K Number
    K113281
    Device Name
    MRI SYTEMS
    Date Cleared
    2012-05-17

    (192 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN ANKE HIGH-TECH CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MRI SYSTEMS, including ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000), are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. These images when interpreted by a trained physician yield information that may assist in diagnosis.
    Device Description
    MRI SYSTEMS include a series of open permanent magnet MRI system with magnetic field strength of 0.3T, 0.4T and 0.5T respectively. The model number for each of the corresponding system is ASM-030PIII (OPENMARK III), ASM-040P (OPENMARK 4000) and ASM-050P (OPENMARK 5000) respectively. They are composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil. RF Transmission Coil. RF Receiver Coil. Client PC, and Imaging Cabinet. The system software, APEX, based on Windows XP® Professional is an interactive program with user friendly interface.
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