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510(k) Data Aggregation

    K Number
    K252195

    Validate with FDA (Live)

    Device Name
    ARTICOR planner
    Manufacturer
    Artiness S.R.L
    Date Cleared
    2026-03-27

    (256 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K220649,K101342,K190874
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ARTICOR planner is intended for use as a software interface and image segmentation system to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, ARTICOR planner provides additional visualization and measurement tools to enable the user to screen and plan the procedure.

    ARTICOR planner should be used in conjunction with other diagnostic tools and expert clinical judgement.

    Device Description

    ARTICOR planner is a software interface that enables the user to plan structural heart and vascular procedures through the following phases:

    1. Analyze anatomy
    2. Plan device
    3. Plan delivery
    4. Output

    The user can create and optimize 3D reconstruction of the patient's anatomy based on DICOM-compliant medical images using a variety of manual and semi-automatic segmentation tools available in a desktop software. These models, and the images from which they are created, can then be used, in an Augmented Reality (AR) environment that communicates with the desktop software through cloud services, to conduct measurements and plan the treatment. In particular, the user can evaluate the sizing and positioning of structural heart and vascular devices and prepare the fluoroscopy angles for the procedure.

    AI/ML Overview

    N/A

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