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510(k) Data Aggregation

    K Number
    K253217

    Validate with FDA (Live)

    Device Name
    MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
    Manufacturer
    Medimaging Integrated Solution, Inc (Miis)
    Date Cleared
    2025-12-23

    (85 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    18 - 99
    Reference & Predicate Devices
    K201134
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MiiS Horus Arthroscope:
    The MiiS Horus Arthroscope is a sterile and single-use device designed for operation with its compatible display system.
    It is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization of an interior cavity of the body through a surgical opening.
    The device is intended for use in a hospital or medical office environment and is designed for use in adults.

    MiiS Horus Endoscope Display System -Tablet:
    The MiiS Horus Endoscope Display System -Tablet is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.

    MiiS Horus Endoscope Display System -Video Box:
    The MiiS Horus Endoscope Display System -Video Box is intend for use with compatible endoscopes to provide visualization for endoscopic diagnosis, treatment, and video observation.

    Device Description

    MiiS Horus Arthroscope is a sterile and single-use device designed to be operated with its compatible display system. The device provides visualization for endoscopic procedures of an interior cavity of the body through a surgical opening.

    The Arthroscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet or MiiS Horus Endoscope Display System -Video Box and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.

    MiiS Horus Endoscope Display System –Tablet is a tablet which showing live image or snapshot from Arthroscope.

    MiiS Horus Endoscope Display System -Video Box is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet or computer.

    AI/ML Overview

    N/A

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