LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K112692
    Device Name
    IDENTIFY
    Manufacturer
    HUMEDIQ GMBH
    Date Cleared
    2012-08-03

    (323 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K062611
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUMEDIQ GMBH

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

    The intended use of the device is to identify the patient specific accessories and to aid in the positioning of a patient during radiation therapy.

    The intended use of the device is to identify the patient specific accessories and to guide the positioning of patients and accessories for radiotherapy procedures. The system uses optical tracking of optical markers and RFID tracking of RFID tags as the method of identifying the patient and the accessories. The system consists of an optical tracking system with optical markers and RFID tracking system including RFID tags, a RFID identification system, a computer workstation, an interlock unit, a handheld controller, Wireless LAN access points, a video camera and calibration tools.

    Device Description

    ldentify displays position and identification information during radio therapy treatment to the user.

    The system uses optical tracking of retro reflective disk markers to find the position of the patient and radiotherapy equipment and radio frequency identification (RFID) to obtain identification information from the patient and radiotherapy equipment.

    The system consists of a PC, a graphical user interface, a NDI Polaris 3D tracking system, a video camera and a RFID reader.

    AI/ML Overview

    The provided text does not contain information about specific acceptance criteria or a study designed to prove the device meets such criteria. The document is a 510(k) summary for the "Identify" system, primarily focusing on its substantial equivalence to a predicate device.

    Instead, the document describes the device, its intended use, and argues for its safety and effectiveness based on similarity to an existing device and compliance with general safety standards. There is no mention of a particular study with a defined test set, ground truth, expert involvement, or statistical analysis to demonstrate performance against specific quantitative acceptance criteria.

    Therefore, I cannot provide the requested table or details about a study for this device based on the given information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1