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510(k) Data Aggregation

    K Number
    K201435
    Device Name
    Molecular Flow Simulations
    Manufacturer
    Therataxis, LLC
    Date Cleared
    2021-12-03

    (550 days)

    Product Code
    HAW, QRI
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Therataxis, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Molecular Flow Simulations is designed as a planning system for pre- and intra-operative planning of stereotactic or image-guided surgeries. It is specially designed to display anatomical images of a patient acquired with magnetic resonance (MR) or computed tomography (CT) scanners as well as images derived from diffusion tensor imaging (DTI) data acquired with MR. Molecular Flow Simulations is a dedicated tool for planning trajectories of intracranial catheters. Guidelines for the catheter placement, such as from catheter suppliers, can be visualized and displayed to support the surgeon in improving catheter placement planning. The guidelines, in combination with anatomical information, can be used to suggest areas that are compliant with the guidelines. Molecular Flow Simulations does not generate or create rules for the placement of intracranial catheters by any means. Molecular Flow Simulations uses MR-DTI and T2- weighted MR images to suggest likely volumes of fluid distribution. The primary mode of action for Molecular Flow Simulations is a device for creating stereotactic or image-guided surgical plans, especially for the creation of plans for the placement of intracranial catheters.
    Device Description
    Molecular Flow Simulations is a software tool running on a standard, standalone computer (PC or Laptop), or being accessible via the intranet connection, that can be used by surgeons for pre- or intraoperative planning of treatments based on stereotactic systems or image guided surgery systems. The system is a software-only medical device to be installed on common IT hardware.
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