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510(k) Data Aggregation

    K Number
    K143485
    Device Name
    iGuide 2.1
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Date Cleared
    2015-03-04

    (86 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K072898,K072079
    Why did this record match?
    Device Name :

    iGuide 2.1

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

    The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

    Device Description

    The iGUIDE 2.1 System is a powered radiation therapy support assembly which provides patient positioning control prior to radiotherapy treatment. iGUIDE 2.1 System consists of the iGUIDE workstation with software, a tracking system, reference frame, calibration tool, isolation transformer, KVM Extender and monitors for the workstation and terminal.

    The iGUIDE software controls the combined working of the HexaPOD evo RT System components and provides status detection via the software GUI to the user. The HexaPOD evo RT System consists of iGUIDE and the HexaPOD evo RT Couchtop, a robotic patient-positioning platform with six degrees of freedom, which is cleared under K072898.

    AI/ML Overview

    This document is a 510(k) summary for the iGUIDE 2.1 system, a medical device for patient positioning in radiotherapy. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (iGUIDE System, K072079).

    Here's a breakdown of the requested information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (from predicate device K072079)Reported Device Performance (iGUIDE 2.1 System)
    Accuracy of 3D Tracking System: Not explicitly stated as "acceptance criteria," but for comparison, the predicate had a reported accuracy of 0.35mm.Accuracy of 3D Tracking System: 0.35mm
    Accuracy of total system (Treatment table + tracking system):
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