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

    MEDICAL IMAGE PROCESSING UNIT

    K Number: K113360 · Decision Feb 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    MEDICAL IMAGE PROCESSING UNIT
    K Number
    K113360
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.1810
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Humanray Co,Ltd
    Date Received
    November 14, 2011
    Decision Date
    February 7, 2012
    Product Code
    EAP
    Advisory Committee
    Dental
    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
    EAP Unit, X-Ray, Intraoral

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    Other Clearances by Humanray Co,Ltd

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