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510(k) Data Aggregation

    K Number
    K251964

    Validate with FDA (Live)

    Device Name
    Mimics Thoracic Planner
    Manufacturer
    Materialise NV
    Date Cleared
    2026-03-12

    (259 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K233217,K183105
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM-compliant medical images.

    The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis.

    The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure.

    The Mimics Thoracic Planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

    Device Description

    The Mimics Thoracic Planner is intended to be used as a pre-procedural planning software to review, analyze and plan pulmonary or thoracic procedures based on DICOM compliant medical images. The Mimics Thoracic Planner allows the clinician to visualize, measure and annotate pre-procedural plan data before and during the procedure, and perform post-op analysis. The Mimics Thoracic Planner allows the clinician to edit pre-procedural plan data before the procedure. The Mimics Thoracic Planner should be used in conjunction with other diagnostic tools and expert clinical judgement. The Mimics Thoracic Planner is an online planning software, which allows the clinician to review and adjust a plan for a surgical procedure of the pulmonary/thoracic anatomy based on DICOM images and 3D models. The planned procedure may be one of the following: segmentectomy, lobectomy, pneumectomy, etc. The Mimics Thoracic Planner software guides the clinician through different steps of the workflow, where the relevant information, like virtual 3D models of anatomy, images and measurements are presented. The software enables the clinician to review the anatomy, evaluate the target lesion, define the resection and assess the pathway to remove the resection. The software provides the tools to adjust all predefined measurements, and to perform custom measurements. The software is integrated with a Medical Device Data System, which is responsible for case management and user management.

    During the procedure, the intra-op step should only be used to visualize the pre-operative plan. Mimics Thoracic Planner is not intended to be used to modify the pre-operative plan during surgery.

    AI/ML Overview

    N/A

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