LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211966
    Device Name
    Segment 3DPrint
    Manufacturer
    Medviso AB
    Date Cleared
    2022-05-06

    (316 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K183105
    Why did this record match?
    Device Name :

    Segment 3DPrint

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

    Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes in both paediativ and adult populations in the field of orthopaedic, maxillofacial, and cardiovascular applications. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabrical replical replical replical replical replical replical replical replical by use of additive manufacturing methods. Segment 3DPrint is intended to be used by trained professionals in conjunction with expert clinical judgement.

    Device Description

    Seqment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models. Segment 3DPrint is intended to generate 3D models for diagnostic purposes. The models can be used for visualisation, measuring, and treatment planning. Output from Segment 3DPrint can be used to fabricate physical replicas, by use of additive manufacturing methods.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study details for the Segment 3DPrint device based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / MetricReported Device Performance
    Accuracy of final 3D model
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1