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510(k) Data Aggregation

    K Number
    K221025
    Device Name
    i_ Field 1.5T Superconducting Magnetic Resonance Imaging System
    Date Cleared
    2022-07-01

    (86 days)

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

    MRI Division,Beijing Wandong Medical Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    i Field 1.5T Superconducting Magnetic Resonance Imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the MRI System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-latice 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 diagnosis determination.
    Device Description
    i Field 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Field 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the i_Space 1.5T by taking advantage of the imaging properties of the 1.5T magnet.
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    K Number
    K192650
    Device Name
    i_Space 1.5T Superconducting Magnetic Resonance Imaging System
    Date Cleared
    2021-01-29

    (493 days)

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

    MRI Division, Beijing Wandong Medical Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    i Space 1.5T Superconducting Magnetic Resonance Imaging device, which is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI System produces transverse, sagittal, coronal, and oblique images that display the internal structure of the head, body, or extremities. The images produced by the MRI System reflect the spatial 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 diagnosis determination.
    Device Description
    i Space 1.5T Superconducting Magnetic Resonance Imaging System utilizes a 1.5 Tesla superconducting magnet in an open gantry design. i Space 1.5T Superconducting Magnetic Resonance Imaging System has been designed to enhance clinical utility as compared to the HHF1 by taking advantage of the imaging properties of the 1.5T magnet.
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    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

    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

    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.
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    K Number
    K042948
    Device Name
    I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM
    Manufacturer
    Date Cleared
    2004-11-03

    (8 days)

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

    WANDONG MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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