LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133007
    Device Name
    DX3000-L
    Manufacturer
    DEXCOWIN CO., LTD
    Date Cleared
    2014-04-24

    (211 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K173046
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DX3000 is a portable x-ray system indicated for taking diagnostic dental x-rays for both pediatic and adult patients using intraoral film or digital sensors

    Device Description

    DX-3000 Portable X-Ray System

    AI/ML Overview

    There is no information in the provided document about acceptance criteria, device performance, test set sample size, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, training set sample size, or how ground truth for the training set was established.

    The document is an FDA 510(k) clearance letter for a dental X-ray system, confirming its substantial equivalence to previously marketed devices. It does not contain efficacy study details.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1