BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN

    K Number: K020561 · Decision May 9, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    21
    Review Days
    78

    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
    SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN
    K Number
    K020561
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tomtec Imaging Systems GmbH
    Date Received
    February 20, 2002
    Decision Date
    May 9, 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 Tomtec Imaging Systems GmbH

    K Number Device Name
    K213544 TOMTEC-ARENA
    K201632 TOMTEC-ARENA
    K150122 TOMTEC-ARENA TTA2
    K132544 TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
    K122289 IMAGE-COM 5.0
    K120135 2D CARDIAC PERFORMANCE ANALYSIS MR 1.0
    K110746 4D LV-ANALYSIS 3.0
    K110667 IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
    K110595 4D SONO-SCAN 1.0
    K103782 4D MV-ASSESSMENT 2.0
    Search all 21 clearances from Tomtec Imaging Systems GmbH →