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

    Z.ONE ULTRA ULTRASOUND SYSTEM

    K Number: K101091 · Decision Jun 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    Z.ONE ULTRA ULTRASOUND SYSTEM
    K Number
    K101091
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zonare Medical Systems, Inc.
    Date Received
    April 19, 2010
    Decision Date
    June 25, 2010
    Product Code
    IYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    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 Zonare Medical Systems, Inc.

    K Number Device Name
    K151175 ZONARE ZS3 Diagnostic Ultrasound System
    K150249 ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System
    K141641 ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM
    K120703 ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
    K082326 ZONARE ULTRA ULTRASOUND SYSTEM