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510(k) Data Aggregation

    K Number
    K022074
    Device Name
    SPHERZ
    Manufacturer
    I.Z.I. CORP.
    Date Cleared
    2002-08-13

    (48 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.Z.I. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy.
    Device Description
    Not Found
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    K Number
    K014022
    Device Name
    MRI LINE MARKER
    Manufacturer
    I.Z.I. CORP.
    Date Cleared
    2002-03-04

    (88 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.Z.I. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use as permanently-filled and -sealed artificial fiduciary markers with the head rings and localizer I brass as permanently and systems in order to facilitate localizing and documenting the precise superimposition of CT and MRI imaging data.
    Device Description
    Not Found
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    K Number
    K003736
    Device Name
    MRI LINE MARKER
    Manufacturer
    I.Z.I. CORP.
    Date Cleared
    2001-01-18

    (45 days)

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

    I.Z.I. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994117
    Device Name
    MR ENHANCER
    Manufacturer
    I.Z.I. CORP.
    Date Cleared
    2000-02-04

    (60 days)

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

    I.Z.I. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo. MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.
    Device Description
    MR Enhancer
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    K Number
    K993742
    Device Name
    SUPER TISSUE
    Manufacturer
    I.Z.I. CORP.
    Date Cleared
    2000-02-02

    (90 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.Z.I. CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue.
    Device Description
    Not Found
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