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

    Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System

    K Number: K173000 · Decision Dec 7, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    8
    Review Days
    71

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    Basic Information

    Device Name
    Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
    K Number
    K173000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
    Date Received
    September 27, 2017
    Decision Date
    December 7, 2017
    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 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

    K Number Device Name
    K210317 Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
    K210318 Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
    K202350 SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
    K202353 SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System
    K200637 SR-8100 Portable X-ray Unit
    K200976 SR-8230, SR-8230S Portable X-ray Unit
    K160853 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System