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510(k) Data Aggregation

    K Number
    K990242
    Device Name
    TOPOGRAPHIC IMAGING MARKER
    Date Cleared
    1999-03-03

    (37 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.Z.I. MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 121 Topographic Imaging Marker provides a location on the patient's skin to reference internal anatomy and pathology. Given any radiographic information thereby, a physician or technician can pinpoint the location of the patient's ailment on the skin surface in reference to an internal pathologic process. The subsequent radiographic study would enable one to cross reference the skin position indicated by the patient with the internally demonstrated pathologic process shown on the study. The IZI Topographic Imaging Marker is used for all fluoroscopic procedures, all standard radiographic procedures, localization of internal anatomy and pathology, as well as being able to direct biopsy procedures.
    Device Description
    Topographic Imaging Marker
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    K Number
    K990298
    Device Name
    TOPOGRAPHIC IMAGING MARKER
    Date Cleared
    1999-03-03

    (30 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.Z.I. MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IZI Topographic Imaging Marker provides a location on the patient's skin to reference internal anatomy and pathology. Given any radiographic information thereby, a physician or technician can pinpoint the location of the patient's ailment on the skin surface in reference to an internal pathologic process. The subsequent radiographic study would enable one to cross reference the skin position indicated by the patient with the internally demonstrated pathologic process shown on the study. The IZI Topographic Imaging Marker is used for all fluoroscopic procedures, all standard radiographic procedures, localization of internal anatomy and pathology, as well as being able to direct biopsy procedures.
    Device Description
    Not Found
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    K Number
    K964972
    Device Name
    SHADOWFORM
    Date Cleared
    1997-05-05

    (144 days)

    Product Code
    Regulation Number
    892.5840
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.Z.I. MEDICAL PRODUCTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K962606
    Device Name
    TOPOGRAPHIC IMAGING MARKER
    Date Cleared
    1996-08-07

    (36 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    I.Z.I. MEDICAL PRODUCTS CORP.

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