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

    CHISON DIAGNOSTIC ULTRASOUND SYSTEM

    K Number: K120801 · Decision Jun 14, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    13
    Review Days
    90

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    Basic Information

    Device Name
    CHISON DIAGNOSTIC ULTRASOUND SYSTEM
    K Number
    K120801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chison Medical Imaging Co., Ltd.
    Date Received
    March 16, 2012
    Decision Date
    June 14, 2012
    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 Chison Medical Imaging Co., Ltd.

    K Number Device Name
    K170870 Site~Rite Halcyon Diagnostic Ultrasound System
    K170374 SonoBook Series Diagnostic Ultrasound System
    K162172 EBit Series Diagnostic Ultrasound System
    K153085 Q Series Diagnostic Ultrasound System
    K150861 QBit Series Diagnostic Ultrasound System
    K140364 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE
    K131305 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
    K121867 SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
    K113359 CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE
    K091877 CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL
    Search all 13 clearances from Chison Medical Imaging Co., Ltd. →