BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM

    K Number: K963395 · Decision Oct 25, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    54
    Applicant Total
    9
    Review Days
    58

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    Basic Information

    Device Name
    IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
    K Number
    K963395
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.2010
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sectra-Imtec AB
    Date Received
    August 28, 1996
    Decision Date
    October 25, 1996
    Product Code
    LMB
    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
    LMB Device, Digital Image Storage, Radiological

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    Other Clearances by Sectra-Imtec AB

    K Number Device Name
    K040376 SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE
    K033712 MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1
    K031590 SECTRA ORTHOPEDIC PACKAGE
    K021527 SECTRA OSTEOPOROSIS PACKAGE
    K002936 MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM
    K983447 WISE (II) IMAGE MANAGEMENT SYSTEM
    K965161 SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
    K961983 TRS 2000 TELERADIOLOGY SYSTEM