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

    ALARA IMAGING SYSTEM

    K Number: K955643 · Decision Mar 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    ALARA IMAGING SYSTEM
    K Number
    K955643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1900
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Denoptix, Inc.
    Date Received
    December 12, 1995
    Decision Date
    March 1, 1996
    Product Code
    EGY
    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
    EGY Processor, Radiographic-Film, Automatic, Dental

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