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510(k) Data Aggregation

    K Number
    K092899
    Device Name
    OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
    Manufacturer
    NINGBO XINGAOYI MAGNETISM CO., LTD.
    Date Cleared
    2009-11-10

    (50 days)

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

    NINGBO XINGAOYI MAGNETISM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OPER Series Open Type Permanent-Magnet MRI 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 OPER Series Open Type Permanent-Magnet 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 determining a diagnosis.
    Device Description
    The OPER Series Open Type Permanent-Magnet MRI System (OPER MRI) is a series of open permanent magnet MRI system, with magnetic field strength of 0.3T, and 0.4T, respectively. The model number for each of the corresponding system is OPER-0.3, OPER-0.35, and OPER-0.4, respectively. The OPER MRI system utilizes a permanent magnet to acquire 2D single-slice and multislice and 3D volume images. A wide range of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery and flow compensation are provided to suppress artifacts due to physiological motion and improve image quality.
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