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

    ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM

    K Number: K954022 · Decision Jan 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    220
    Registration Numbers
    220
    Same Product Code
    1171
    Applicant Total
    39
    Review Days
    142

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    Basic Information

    Device Name
    ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM
    K Number
    K954022
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1550
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aloka Co., Ltd.
    Date Received
    August 28, 1995
    Decision Date
    January 17, 1996
    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 Aloka Co., Ltd.

    K Number Device Name
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    K093488 ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM
    K083254 ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
    K081843 ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
    K080176 ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM
    K072285 ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM
    K060059 ALOKA SD-3500 ULTRASOUND SYSTEM
    K043196 ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM
    K040719 ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
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