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510(k) Data Aggregation

    K Number
    K990153
    Device Name
    VIRGO MRI SYSTEM
    Date Cleared
    1999-10-08

    (262 days)

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

    MILLENNIUM TECHNOLOGY SERVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.
    Device Description
    The Vaya MRI SYSTEM is functionally similar to most existing MRI systems. General specifications are as follows: Magnet Subsystem 0.35 Telsa C-Shaped Compact Permanent Magnet Optimized Pole Design Homogeneity +/- 10 ppm with30 cm DSV Dimension 110cm x 160cm x 180cm Detachable Patient Table 2nd Detachable Patient Table Gradient Subsystem Strenath: 10mT/m Rise Time: 0.6ms Air Cooled RF Subsystem Quadrature Head Coil Quadrature Body/Spine Coil 3 Solenoid Coils for Extremities, Shoulder and C Spine Low Noise Preamplifier (0.5 dB Noise Figure) Digital RF Electronics Maximum Transmitter Power 5kW Computer System Host Computer: Dual Pentium CPU True Multi-tasking NT Environment All JAVA Language Programming RAM: 128MB Hard Disk: 2.1GB Image Capacity: 9000 256x256 1.7 GB WORM Archiving Remote System Maintenance Console Patient Registration Scanning Post-Processing & Image Enhancement (option) Display & Analysis Package Archiving User Defined Protocols User Specific Menus View Console (option) DICOM Compliant Laser Camera Interface Via 3M Protocol Laser Camera (option) CD Rewritable Drive (option) Protocols As Described on the Intended Use Page Site Requirements 5 Gauss Line 15" x 15" Maximum 3 Phase AC Power20kVA No Water Requirement
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