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510(k) Data Aggregation

    K Number
    K173689
    Device Name
    Ophthalmic Software Platform RX
    Manufacturer
    Canon Inc. -Medical Equipment Group
    Date Cleared
    2018-02-23

    (84 days)

    Product Code
    NFJ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K132438
    Why did this record match?
    Device Name :

    Ophthalmic Software Platform RX

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

    The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic retinal cameras.

    Device Description

    The Ophthalmic Software Platform RX is an ophthalmic software system indicated for acquiring, storing, managing, processing, and display of patient, diagnostic, image data from Canon's mydriatic and non-mydriatic retinal cameras.

    The Ophthalmic Software Platform RX consists of three types of software including the RX Capture for Retinal Camera, RX Server and RX Viewer.

    RX Capture for Retinal Camera software: This is a software executed on a Capture PC. This software acquires images from a retinal camera that the control software captures and puts on the Capture PC. This software acquires images of eye, stores images and processes images. Also, this software displays acquired and processed images which are stored in a Server's database.

    RX Viewer software: This is a software executed on a Viewer PC. This software processes images and displays acquired and processed images which are stored on the RX Capture for Retinal Camera or RX Server's database.

    RX Server software: This is a software executed on a Viewer PC. This software stores images, processes images and displays acquired and processed images which are stored in its' own database.

    AI/ML Overview

    This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary for the Ophthalmic Software Platform RX, which details its substantial equivalence to a predicate device (Topcon IMAGEnet 5 PC Software System - K132438).

    The document focuses on demonstrating that the new device has:

    • The same intended use.
    • Similar indications for use.
    • Similar principles of operation.
    • Similar technological characteristics.

    Therefore, it concludes that the Ophthalmic Software Platform RX is as safe and effective as its predicate device. The information provided is typical for a 510(k) submission, which aims to demonstrate substantial equivalence rather than provide a detailed performance study with acceptance criteria.

    Specifically, the document states:

    • "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' The software for this device was considered as a 'moderate' level of concern." (Page 5, Section i. Software Verification and Validation)

    This statement indicates that V&V was performed according to general FDA guidance for software, but it does not provide the specific acceptance criteria, method of testing, or results of a study that would address the information requested regarding device performance.

    Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided text.

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