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510(k) Data Aggregation

    K Number
    K080048
    Device Name
    MSK EXTREME MR SCANNER, MODEL AA5000
    Manufacturer
    ONI MEDICAL SYSTEMS, INC.
    Date Cleared
    2008-02-06

    (29 days)

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

    ONI MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ONI MSK Extreme™ MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.
    Device Description
    The MSK Extreme™ MR Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety 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, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.
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    K Number
    K012009
    Device Name
    MX8000 IDT CT SYSTEM
    Manufacturer
    MARCONI MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-09-13

    (78 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARCONI MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
    Device Description
    The Mx8000 IDT is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 16 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
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    K Number
    K002005
    Device Name
    BOLUSPRO ULTRA
    Manufacturer
    MARCONI MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-09-22

    (81 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    MARCONI MEDICAL SYSTEMS, INC.

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