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

    7200 ULTRASOUND IMAGING SYSTEM

    K Number: K981293 · Decision Jun 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    20
    Review Days
    82

    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
    7200 ULTRASOUND IMAGING SYSTEM
    K Number
    K981293
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosound Esaote, Inc.
    Date Received
    April 9, 1998
    Decision Date
    June 30, 1998
    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 Biosound Esaote, Inc.

    K Number Device Name
    K023255 TECHNOS MP, MODEL AU6
    K014168 AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
    K020164 E-SCAN XQ
    K012728 E-SCAN MRI SYSTEM
    K010405 7230 ULTRASOUND IMAGING SYSTEM WITH TEI
    K010057 MODIFICATION TO ARTOSCAN M
    K001894 MODIFICATION TO E-SCAN
    K000931 AU5 ULTRASOUND IMAGING SYSTEM
    K000681 AU5, AU6
    K994369 7250 (MEGAS)
    Search all 20 clearances from Biosound Esaote, Inc. →