LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183695
    Device Name
    OrthoAnalysis Software
    Manufacturer
    Inteware Co., Ltd.
    Date Cleared
    2019-09-12

    (255 days)

    Product Code
    PNN
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    OrthoAnalysis software is designed for use as a medical device providing tools for orthodontic model design and export, inspection, analysis and treatment simulation.

    The use of the OrthoAnalysis software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) clearance letter for "OrthoAnalysis Software" (K183695) primarily establishes substantial equivalence to a predicate device and outlines the general regulatory requirements. It does not contain information regarding specific acceptance criteria, a study proving device performance, sample sizes for test sets, expert qualifications, or details about training sets.

    Therefore, I cannot provide a detailed answer to your request based on the provided input. This document is a regulatory clearance, not a technical performance report or a clinical study summary.

    In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria and study details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1