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

    I.S.G. 3DMV WORKSTATION

    K Number: K872150 · Decision Aug 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    818
    Applicant Total
    10
    Review Days
    69

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    Basic Information

    Device Name
    I.S.G. 3DMV WORKSTATION
    K Number
    K872150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1750
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    I.S.G. Technologies, Inc.
    Date Received
    June 4, 1987
    Decision Date
    August 12, 1987
    Product Code
    JAK
    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
    JAK System, X-Ray, Tomography, Computed

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

    K Number Device Name
    K993673 SNN FLUORO NAVIGATION SYSTEM
    K982570 SNN SCOUT
    K980684 VR NETSERVE
    K973413 ID. STORE (RELEASE 2.0)
    K970865 ISG FAMILY OF VIEWING WANDS
    K960714 ISG VIEWING WAND
    K941933 ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)
    K911783 ALLEGRO VIEWING WAND
    K901679 RESUBMITTED ISG 3DMV WORKSTATION