LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K043086
    Device Name
    SOMATOM RESPIRATORY GATING
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Date Cleared
    2004-12-23

    (45 days)

    Product Code
    JAK,SOM
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K023687,K040665,K040577
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Respiratory Gating is an option for CT scanners of the Sensation and the Emotion family. This application provides an improvement of the image quality by removing the artifacts caused by respiratory motion.

    Device Description

    The computed tomography system in combination with a device for Respiratory Gating is intended for the removal of the artifacts caused by respiratory motion. This leads to an increase of the image quality and advancement in diagnosis because the movement of organs or tumors can be visualized against the respiration phases.

    AI/ML Overview

    This document does not contain the information necessary to fulfill your request. It is a 510(k) summary for a Siemens Respiratory Gating device, outlining its substantial equivalence to previously cleared devices.

    Specifically, it lacks:

    • A table of acceptance criteria and reported device performance.
    • Details about any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.

    The document primarily focuses on regulatory submission details such as contact information, device classification, and indications for use, rather than detailed performance data or study specifics.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1