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510(k) Data Aggregation

    K Number
    K963186
    Device Name
    ORTHO 8000
    Date Cleared
    1996-11-12

    (90 days)

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

    INNER VISION MRI LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Anatomical region : Extremities Nuclei excited Diagnostic uses : 2D imaging, 3D imaging
    Device Description
    Model Name : Ortho 8000 Isotope : Proton Imaging Model Characteristics Magnet Permanent 0.17 Tesla Static Field strength +/-20ppm over 16cm DSV Homogeneity RF Coil Types - Leg coil l Transmit/receive coil for knee/foot/ankle/leg/elbow 15 cm Diameter x 8 cm Length - 2. Arm Coil Transmit/receive coil for hand/wrist/forearm 10 cm Diameter x 6 cm Length - 3 18 cm Loop Coil Transmit/receive coil for general purpose use - 4 12 cm Loop Transmit/receive coil for general purpose use Data Acquisition Modes Phase and frequency encoding to sample k-space 2D Multiple Slice 2D Multiple Slice, Multiple Echo 3D Multiple Slice Pulse Sequences Spin echo Gradient (Field) echo Inversion recovery Dynamic imaging These sequences can provide T1 weighted, T2 weighted, T2* weighted images Reconstruction Techniques 2D Fourier Transform 3D Fourier Transform Type of Installation Fixed Site Slice Selection Methods Selective excitation in the presence of a field gradient Phase encoding for 3D Display Matrix 256 x 256 1 - 4 Simultaneous Images Acquisition Matrix 64 - 256 in steps of 1 for the phase encoding direction 256 in the frequency encoding direction Image Acquisition Time 2D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps 3D - Repeat Time x Number of Excitations x Number of Phase Encoding Steps x Number of Slice Encoding Steps Image Pre and Post Processing Magnitude Value Pixel Value Horizontal/Vertical Line Profiles Spatial Filtering - Hamming Filter in Frequency and Phase Directions Number of Slices, Range and Increment 2D - 1-16 in steps of 1 3D - 16 slice only Slice Orientation Transverse (Axial) Sagittal Coronal Oblique 3 Orthogonal Plane Scouts Interslice Spacing, minimum, maximum and increment 0 mm, 10mm, Increment 1 mm
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