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510(k) Data Aggregation

    K Number
    K090080
    Device Name
    CIRRUS OPEN
    Manufacturer
    MRI-TECH SP. ZO.O.
    Date Cleared
    2009-03-23

    (70 days)

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

    MRI-TECH SP. ZO.O.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cirrus Open is an open, 0.2 Tesla MR imaging device intended to provide a physician with physiological and clinical information obtained non-invasively using magnetic resonance imaging (MRI) without the use of ionizing radiation. Cirrus Open is indicated for use as a diagnostic imaging device to produce images in the transverse, sagittal, coronal and oblique scan planes of a patient's head. The images produced by Cirrus Open reflect the spatial distribution of protons (hydrogen nuclei). The magnetic properties that determine the appearance of images are proton density, spin-lattice relaxation time (T1), spinspin relaxation time (T2) and T2* relaxation time. Additional contrasts that can be used include magnetization transfer and diffusion. When interpreted by a trained physician, these images provide information that can be useful in diagnosis.
    Device Description
    Cirrus Open is a Magnetic Resonance Imaging (MRI) System that utilizes a 0.2 Tesla permanent magnet to acquire 2D single and multi slice, and 3D volume images of a patient's head in the transverse, sagittal, coronal and oblique scan planes using pulse sequences such as spin echo, gradient echo, inversion recovery, driven equilibrium and free procession acquisitions. The open, fourpost magnet system helps maintain a patient's connection to the external environment and offers MR personnel convenient access to the patient from all four directions. The patient bed system is manually operated by a push or pull from the hand of the MR personnel. The bed top has six, numbered discreet locating positions for placement of the radio frequency (RF) coil. By inserting the bed into the magnet to one of its six, numbered snap-in (detent) locations, that matches the numbered position of the RF coil placement, the patient region of interest is conveniently placed at magnet iso-centre. The MR console station allows the operator to enter patient registration information, and to select, edit and execute the required scan protocols. The MR console operator can also store, review and print image data.
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