LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033486
    Device Name
    GE PRECISION MPI
    Manufacturer
    NRT-NORDISK RONTGEN TEKNIK A/S
    Date Cleared
    2003-11-19

    (15 days)

    Product Code
    OWB, LEG
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    NRT-NORDISK RONTGEN TEKNIK A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GE Precision MPi is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. The GE Precision MPi is a multi-purpose system that can perform general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
    Device Description
    The GE Precision MPi tilt-C consists of an X-ray Generator, Right or Left side suspended Angulations Table with X-ray Tube, Collimator and Image Intensifier, Operators console, and Digital Imaging/Archive system.
    Ask a Question

    Page 1 of 1