Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K142323
    Device Name
    Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL LTD.
    Date Cleared
    2014-10-10

    (51 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE MEDICAL SYSTEMS ISRAEL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal (Including Renal & Gyn); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatrics); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate) and Transesophageal.
    Device Description
    The Vivid S60/S70 is a Track 3 diagnostic ultrasound system, which is primarily intended for echocardiography imaging and analysis, with additional capability in vascular and general ultrasound imaging. The Vivid S60/S70 incorporates a variety of electronic array transducers that provide digital acquisition, processing and display capabilities, and operate in linear, curved linear, sector/ phased array format or matrix array format, including CW transducer and a real time 3D transducer. Vivid S60/S70 consists of a mobile console approximately 56 cm wide 77 cm deep and 120 cm high, and includes multiple electronic array transducers that provide digital acquisition, processing and display capabilities. The user interface includes a variable height rotatable, user control panel with specialized controls, a 19-inch wide screen LCD display and a separate 12.1-inch touch panel with a resolution of 1280x800 with multi-touch capabilities.
    Ask a Question

    Page 1 of 1