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510(k) Data Aggregation

    K Number
    K050132
    Device Name
    NEURO II-S
    Date Cleared
    2005-02-15

    (25 days)

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

    INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IMRIS Neuro II-S MRI system is indicated for use for the whole body. The Neuro II-S is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that: 1. correspond to the distribution of protons exhibiting MR characteristics; 2. depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and 3. display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Neuro II-S may also be used during intra-operative procedures when performed in an intra- operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
    Device Description
    The IMRIS Neuro II-S Intra-operative MRI system is a traditional 1.5T MRI system that has been suspended from an overhead gantry to facilitate intra-operative use. The main components of the Neuro II-S system are the MRI system assembly ( including diagnostic RF coils), the magnet mover assembly, the OR patient table assembly and the intra-operative RF coil.
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    K Number
    K002964
    Device Name
    NEURO II
    Date Cleared
    2000-12-19

    (88 days)

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

    INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC.

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