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

    SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT

    K Number: K910426 · Decision Jun 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    29
    Applicant Total
    90
    Review Days
    127

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    Basic Information

    Device Name
    SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
    K Number
    K910426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2225
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Shimadzu Medical Systems
    Date Received
    January 30, 1991
    Decision Date
    June 6, 1991
    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 Shimadzu Medical Systems

    K Number Device Name
    K082224 DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
    K071287 ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
    K071289 ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
    K071291 ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
    K061643 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
    K061637 ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
    K061641 ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO
    K052500 DAR-8000F
    K052076 DAR-8000I
    K050510 ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100
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