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510(k) Data Aggregation

    K Number
    K090873
    Device Name
    I OPEN 0.5T
    Date Cleared
    2009-04-10

    (10 days)

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

    BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The i Open 0.5T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the i Open 0.5T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
    Device Description
    The i_Open 0.5T is a 0.5 Tesla permanent MRI system. The magnet is mainly made of Nd-B-Fe material. The system software based on Windows XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing.
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    K Number
    K090433
    Device Name
    I_OPEN 0.4T
    Date Cleared
    2009-03-25

    (34 days)

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

    BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The i Open 0.4T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the i Open 0.4T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
    Device Description
    The i Open 0.4T is a 0.4 Tesla permanent MRI system. The magnet is mainly made of Nd-B-Fe material. The system software based on Windows XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing.
    Ask a Question

    Ask a specific question about this device

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