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

    Encompass 15 Channel Head Coil, 3T

    K Number: K190668 · Decision Sep 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    487
    Applicant Total
    7
    Review Days
    178

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    Basic Information

    Device Name
    Encompass 15 Channel Head Coil, 3T
    K Number
    K190668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qfix
    Date Received
    March 15, 2019
    Decision Date
    September 9, 2019
    Product Code
    MOS
    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
    MOS Coil, Magnetic Resonance, Specialty

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    Other Clearances by Qfix

    K Number Device Name
    K230312 Iris AirShuttle™
    K193243 Alta Multipurpose Device
    K182189 Encompass SRS Headframe ; Encompass MR SRS Headframe
    K171133 Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories
    K160627 Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution
    K152321 kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm opening