BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    ULTRASOUND SCANNER FLEX FOCUS

    K Number: K123254 · Decision Feb 13, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    11
    Review Days
    118

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    Basic Information

    Device Name
    ULTRASOUND SCANNER FLEX FOCUS
    K Number
    K123254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-K Medical Aps
    Date Received
    October 18, 2012
    Decision Date
    February 13, 2013
    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 B-K Medical Aps

    K Number Device Name
    K140428 ULTRASOUND SCANNER SYSTEM BK2300
    K132335 ULTRASOUND SCANNER FLEX FOCUS 1202
    K132346 ULTRASOUND SCANNER PRO FOCUS 2202
    K132677 ULTRASOUND SCANNER FLEX FOCUS 1202
    K132685 ULTRASOUND SCANNER PRO FOCUS 2202
    K100919 PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
    K083667 NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
    K081323 BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
    K081154 ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
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