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510(k) Data Aggregation

    K Number
    K020993
    Device Name
    ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)
    Manufacturer
    Date Cleared
    2002-05-21

    (55 days)

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

    MAGNA-LAB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil.
    Device Description
    The Illuminator™ Automatic Tuning Interface Box (ATIB) provides an interface for the Illuminator™ Transesophageal Probe, the Illuminator ™ Surface Coil and the General Electric 1.5 T Signa® Magnetic Resonance Imaging (MRI) Systems. The device automatically tunes the Transesophageal (TE) Probe and matches the impedance of the probe to the interface of the MRI system. The Auto Tune Interface Box will be used in clinical MRI rooms. The interface box interfaces with the GE MRI machine through a cable bundle with a 30 pin connector box attached.
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    K Number
    K010513
    Device Name
    CARDIAC VIEW, MODEL 2001
    Manufacturer
    Date Cleared
    2001-05-21

    (89 days)

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

    MAGNA-LAB, INC.

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