BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    HD80 Series Ultrasound Diagnostic System

    K Number: K233841 · Decision May 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    9
    Review Days
    164

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    Basic Information

    Device Name
    HD80 Series Ultrasound Diagnostic System
    K Number
    K233841
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qingdao Hisense Medical Equipment Co., Ltd.
    Date Received
    December 4, 2023
    Decision Date
    May 16, 2024
    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 Qingdao Hisense Medical Equipment Co., Ltd.

    K Number Device Name
    K233439 HD60 Series Ultrasound Diagnostic System
    K222208 Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
    K222132 Hisense LCD monitor HMD2G21S, HMD3G21S
    K221567 LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
    K213862 HD60 Series Ultrasound Diagnostic System
    K160347 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
    K152030 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)
    K151709 Hi-Light Diagnostic Ultrasound Systems