BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    CUBEScan BioCon-900S

    K Number: K200749 · Decision May 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    CUBEScan BioCon-900S
    K Number
    K200749
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mcube Technology Co., Ltd.
    Date Received
    March 23, 2020
    Decision Date
    May 19, 2020
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Mcube Technology Co., Ltd.

    K Number Device Name
    K201995 CUBEScan BioCon-1100
    K200548 CUBEScan BioCon-1100
    K171591 CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
    K111021 CUBESCAN / BIOCON-700
    K091518 CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM