BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    INSTATRAK

    K Number: K960330 · Decision Apr 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    7
    Review Days
    75

    Basic Information

    Device Name
    INSTATRAK
    K Number
    K960330
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    VISUALIZATION TECHNOLOGY, INC.
    Date Received
    January 24, 1996
    Decision Date
    April 8, 1996
    Product Code
    LLZ
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LLZ System, Image Processing, Radiological

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    Other Clearances by VISUALIZATION TECHNOLOGY, INC.

    K Number Device Name
    K003510 INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
    K994270 INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
    K990919 STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG
    K983529 INSTATRAK 3000
    K982994 SKULL BASE INSTATRAK SYSTEM
    K981998 PEDIATRIC INSTATRAK SYSTEM