BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    ISG FAMILY OF VIEWING WANDS

    K Number: K970865 · Decision Jun 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    10
    Review Days
    86

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    Basic Information

    Device Name
    ISG FAMILY OF VIEWING WANDS
    K Number
    K970865
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    I.S.G. Technologies, Inc.
    Date Received
    March 10, 1997
    Decision Date
    June 4, 1997
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

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    Other Clearances by I.S.G. Technologies, Inc.

    K Number Device Name
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    K973413 ID. STORE (RELEASE 2.0)
    K960714 ISG VIEWING WAND
    K941933 ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)
    K911783 ALLEGRO VIEWING WAND
    K901679 RESUBMITTED ISG 3DMV WORKSTATION
    K872150 I.S.G. 3DMV WORKSTATION