LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082243
    Device Name
    PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
    Manufacturer
    GENERAL MEDICAL MERATE S.P.A.
    Date Cleared
    2008-11-07

    (92 days)

    Product Code
    OWB,IZI,JAA
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

    Device Description

    The PRECISION RXi System was originally cleared by the FDA under 510(k) K041605. This submission describes design changes including modifications to the positioner tilting/elevating movement and the compressor.

    AI/ML Overview

    This document does not contain the specific information required to answer your request. The provided text is a 510(k) premarket notification for an X-ray system, focusing on its classification, indications for use, and design changes. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in evaluation.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and the study proving the device meets them based on the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1