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

    SONOACE 88 PORTABLE ULTRASOUND SCANNER

    K Number: K900505 · Decision Aug 10, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    29
    Applicant Total
    24
    Review Days
    189

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    Basic Information

    Device Name
    SONOACE 88 PORTABLE ULTRASOUND SCANNER
    K Number
    K900505
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2225
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Medison Co., Ltd.
    Date Received
    February 2, 1990
    Decision Date
    August 10, 1990
    Product Code
    HEM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HEM Imager, Ultrasonic Obstetric-Gynecologic

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    Other Clearances by Medison Co., Ltd.

    K Number Device Name
    K103397 ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
    K103722 THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
    K102065 SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
    K101455 EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
    K101829 THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM
    K100186 MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
    K093849 ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM
    K093714 SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM
    K092159 ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
    K081676 SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
    Search all 24 clearances from Medison Co., Ltd. →