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

    UST-969-5 CONVEX TRANSDUCER

    K Number: K905391 · Decision Jan 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    136
    Review Days
    62

    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
    UST-969-5 CONVEX TRANSDUCER
    K Number
    K905391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Ge Medical Systems Information Technologies
    Date Received
    November 30, 1990
    Decision Date
    January 31, 1991
    Product Code
    ITX
    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
    ITX Transducer, Ultrasonic, Diagnostic

    Similar 510(k) Clearances

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

    ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Mendaera Guidance System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Accuro® 3S Needle Guide Kit

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ultrasound Transducer Cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    UltraDrape UGPIV Barrier and Securement (34-15)

    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 →