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    K Number
    K031256
    Device Name
    XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
    Manufacturer
    OLYMPUS OPTO-ELECTRONICS CO., LTD.
    Date Cleared
    2003-07-23

    (93 days)

    Product Code
    FDA
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE

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

    This instrument has been designed to be used with the OLYMPUS EVIS Video System Center, EVIS Universal Light Source, Documentation Equipment, Video Monitor, Endo-Therapy Accessories (such as a Forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the small intestine.

    Device Description

    The subject device, the XSIF-1TQ140 is basically identical to the preamendment device, the SIF-B except that the mechanical structure of variable stiffness has been added and the imaging system has been changed from fiber to CCD.

    AI/ML Overview

    This document is a 510(k) premarket notification for an Olympus XSIF-1TQ140A Small Intestinal Videoscope and its accessories (XB01-681-26 Stylet and ST-S1 Splinting Tube). It is a traditional submission, not one related to AI/ML.

    Therefore, the requested information about acceptance criteria, study details, ground truth, and training set for an AI/ML device is not applicable to this document.

    The document discusses the substantial equivalence of the new device to previously marketed predicate devices based on design, materials, and intended use, rather than a performance study against specific acceptance criteria in the context of AI/ML.

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