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510(k) Data Aggregation

    K Number
    K020268
    Device Name
    ISAAC 1.5 T MR SYSTEM
    Manufacturer
    Date Cleared
    2002-04-25

    (90 days)

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

    CHI, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis.
    Device Description
    The ISAAC 1.5 T MR System is a new clinical whole-body MR system, utilizing a superconducting magnet operating at 1.5 T. A variety of pulse sequences are available as described in Section II. The system is provided with transmit/receive head and body coils, along with several receive-only specialty coils. The system utilizes an actively shielded gradient coil.
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    K Number
    K962107
    Device Name
    IOVES,CORTINA CLUB EYEWEAR,LOUTTESRLG5
    Manufacturer
    Date Cleared
    1996-06-20

    (20 days)

    Product Code
    Regulation Number
    886.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEONACHI, INC.

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