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

    KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT

    K Number: K961739 · Decision Nov 14, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    599
    Registration Numbers
    599
    Same Product Code
    2271
    Applicant Total
    6
    Review Days
    195

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    Basic Information

    Device Name
    KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT
    K Number
    K961739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kodak Health Imaging Systems, Inc.
    Date Received
    May 3, 1996
    Decision Date
    November 14, 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 Kodak Health Imaging Systems, Inc.

    K Number Device Name
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    K961768 KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
    K960981 KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
    K951807 KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER
    K951948 KODAK XLS 8600 (PS)