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

    Lumify Diagnostic Ultrasound System

    K Number: K232500 · Decision Oct 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    Lumify Diagnostic Ultrasound System
    K Number
    K232500
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Ultrasound
    Date Received
    August 17, 2023
    Decision Date
    October 26, 2023
    Product Code
    IYN
    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
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

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    Other Clearances by Philips Ultrasound

    K Number Device Name
    K242519 Lumify Diagnostic Ultrasound System
    K242670 Lumify Diagnostic Ultrasound System
    K223771 Lumify Diagnostic Ultrasound System
    K040227 QLAB QUANTIFICATION SOFTWARE