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

    ADR REAL-TIME SECTOR SCANNER

    K Number: K792446 · Decision Jan 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    10
    Review Days
    40

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    Basic Information

    Device Name
    ADR REAL-TIME SECTOR SCANNER
    K Number
    K792446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Adr Ultrasound
    Date Received
    November 30, 1979
    Decision Date
    January 9, 1980
    Product Code
    IYO
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic

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    Other Clearances by Adr Ultrasound

    K Number Device Name
    K840408 LINEAR ARRAY TRANSDUCER OR SCANHEAD
    K834141 ULTRASOUND SCAN HEAD 3.5 MHZ
    K833224 BIFOCAL 3.0MHZ
    K828049 ADR ULTRASOUND MC2 LARGE CART
    K828051 ADR ULTRASOUND MODEL 4000 SC OR 4000 S/LC
    K828053 ADR ULTRASOUND 5.5 MHZ SHORT FOCUS TRANSDUCER
    K828050 ADR ULTRASOUND MODEL 4000 L
    K813543 ADR ULTRASOUND MODELS 4000S & 4000S/L
    K812301 VARIABLE FOCUS 3.5 MHZ TRANSDUCER