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

    Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax

    K Number: K173639 · Decision Apr 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    319
    Applicant Total
    32
    Review Days
    129

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    Basic Information

    Device Name
    Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
    K Number
    K173639
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1650
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medi Cal Solutions, Inc.
    Date Received
    November 24, 2017
    Decision Date
    April 2, 2018
    Product Code
    OWB
    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
    OWB Interventional Fluoroscopic X-Ray System

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