LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K161706
    Device Name
    Vivid iq
    Manufacturer
    GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L
    Date Cleared
    2016-08-05

    (46 days)

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

    GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vivid ig is a high-performance compact ultrasound for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatal Cephalic, Adult Cephalic, Adult Cephalic, Cardiac, Penpheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal, Transcranial, Transvectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.
    Device Description
    The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. It offers an innovative ergonomic design, superb image quality, advanced connectivity, productivity tools and advanced technology. Compatibility with the Vivid product family offers flexibility in lab configuration and upgrade opportunities.
    Ask a Question

    Page 1 of 1