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510(k) Data Aggregation

    K Number
    K253122

    Validate with FDA (Live)

    Device Name
    Sim&Size
    Manufacturer
    Date Cleared
    2025-12-23

    (89 days)

    Product Code
    Regulation Number
    892.2050
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement of neurointerventional devices.

    General functionalities are provided such as:

    • Segmentation of neurovascular structures
    • Automatic centerline detection
    • Visualization of X-Ray based images for 2D review and 3D reconstruction
    • Placing and sizing tools
    • Reporting tools

    Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.

    Device Description

    Sim&Size is a Software as a Medical Device (SaMD) for simulating neurovascular implantable medical devices. The product enables visualization of cerebral blood vessels for preoperational planning for neurovascular interventions and surgery. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of simulating neurovascular implantable medical devices in the artery or in the aneurysm to be treated through endovascular surgery and provides support in the treatment for the sizing and positioning of implantable medical devices.

    Each type of implant device is simulated in a simulation module of Sim&Size:

    • FDsize, a module that allows pre-operationally planning Flow-Diverter (FD) devices.
    • IDsize, a module that allows pre-operationally planning Intrasaccular (ID) devices.
    • STsize, a module that allows pre-operationally planning Stent (ST) devices.
    • FCsize, a module that allows pre-operationally planning First and filling coils (FC) devices.
    AI/ML Overview

    N/A

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