BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    ULTRASOUND SCANNER, TYPE 1101

    K Number: K023457 · Decision Nov 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    7
    Review Days
    17

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ULTRASOUND SCANNER, TYPE 1101
    K Number
    K023457
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B-K Medical A/S
    Date Received
    October 15, 2002
    Decision Date
    November 1, 2002
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IYO), ordered by most recent decision date.

    ARTHUR

    FDA 510(k)
    FDA Class 2 ·Radiology

    EdgeFlow UW20

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro XV

    FDA 510(k)
    FDA Class 2 ·Radiology

    QT Scanner 2000 Model A

    FDA 510(k)
    FDA Class 2 ·Radiology

    IntraSight Plus

    FDA 510(k)
    FDA Class 2 ·Radiology

    Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by B-K Medical A/S

    K Number Device Name
    K043554 ULTRASOUND SCANNER MINI FOCUS, MODEL 1402
    K043524 ULTRASOUND SCANNER PRO FOCUS, MODEL 2202
    K024236 ULTRASOUND SCANNER, TYPE 2400
    K011417 ULTRASOUND SCANNER, TYPE 2102
    K003986 ULTRASOUND SCANNER TYPE 2102
    K003041 ULTRASOUND SCANNER TYPE 2101