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

    HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM

    K Number: K033248 · Decision Oct 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    100
    Review Days
    13

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    Basic Information

    Device Name
    HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
    K Number
    K033248
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hitachi Medical Systems America, Inc.
    Date Received
    October 7, 2003
    Decision Date
    October 20, 2003
    Product Code
    MUH
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MUH System, X-Ray, Extraoral Source, Digital

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