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

    ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM

    K Number: K900805 · Decision Aug 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    348
    Registration Numbers
    349
    Same Product Code
    892
    Applicant Total
    136
    Review Days
    183

    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
    ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
    K Number
    K900805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    February 21, 1990
    Decision Date
    August 23, 1990
    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 Ge Medical Systems Information Technologies

    K Number Device Name
    K120770 QT GUARD PLUS ANALYSIS SYSTEM
    K102426 CARESCAPE MODEL V100 VITAL SIGNS MONITOR
    K092369 12SL ECG ANALYSIS PROGRAM
    K093141 MARS HOLTER ANALYSIS WORKSTATION
    K092027 CARESCAPE MONITOR B850
    K090702 MODIFICATION TO DASH 2500 PATIENT MONITOR
    K083750 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM
    K083639 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
    K082851 MULTLINK CABLE AND LEADWIRE SYSTEM
    K081437 MAC 1600 ECG ANALYSIS SYSTEM
    Search all 136 clearances from Ge Medical Systems Information Technologies →