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

    ALLEGRO VIEWING WAND

    K Number: K911783 · Decision Apr 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    609
    Registration Numbers
    609
    Same Product Code
    2221
    Applicant Total
    10
    Review Days
    1081

    Basic Information

    Device Name
    ALLEGRO VIEWING WAND
    K Number
    K911783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    I.S.G. TECHNOLOGIES, INC.
    Date Received
    April 22, 1991
    Decision Date
    April 7, 1994
    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 I.S.G. TECHNOLOGIES, INC.

    K Number Device Name
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    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)
    K901679 RESUBMITTED ISG 3DMV WORKSTATION
    K872150 I.S.G. 3DMV WORKSTATION