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

    UC-5000 Mobile X-Ray

    K Number: K163063 · Decision Dec 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    235
    Applicant Total
    8
    Review Days
    40

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    Basic Information

    Device Name
    UC-5000 Mobile X-Ray
    K Number
    K163063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1720
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Source-Ray, Inc.
    Date Received
    November 2, 2016
    Decision Date
    December 12, 2016
    Product Code
    IZL
    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
    IZL System, X-Ray, Mobile

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    Other Clearances by Source-Ray, Inc.

    K Number Device Name
    K133959 PODIATRY X-RAY SYSTEM
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    K062472 OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
    K052001 MODEL SR-115 PORTABLE X-RAY SYSTEM
    K043062 MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
    K030494 SR-130