LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K061114
    Device Name
    WDS, SIZE 2 AND SIZE 2
    Manufacturer
    CEFLA S.C.R.L.
    Date Cleared
    2006-06-06

    (46 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Abbreviated
    Panel
    Radiology
    Reference & Predicate Devices
    K031448,K050693,K990002
    Why did this record match?
    Device Name :

    WDS, SIZE 2 AND SIZE 2

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

    the wireless digital RX sensor is intended to capture an intraoral digital RX image, when exposed to X-Rays, for diagnostic purposes. The process is automatic and continues transmitting to a Personal Computer the digital image by wireless Bluetooth connection.

    Device Description

    WDS is a wireless digital X-ray sensor for intraoral radiography.

    AI/ML Overview

    The provided text is a 510(k) summary for the WDS Wireless Digital X-ray Sensor, indicating its intended use and establishing substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment.

    Therefore, I cannot provide the requested table or detailed answers to the specific questions regarding acceptance criteria and study particulars, as this information is not present in the provided document.

    The document primarily focuses on:

    • Device Description: WDS is a wireless digital X-ray sensor for intraoral radiography.
    • Intended Use: To capture intraoral digital X-ray images for diagnostic purposes and transmit them wirelessly to a PC.
    • Substantial Equivalence Comparison: Claiming substantial equivalence to predicate devices (K031448 RSV VISIODENT, K050693 ACCENT, K990002 QUICKRAY DSX730) based on similar components, design, technical characteristics, and mode of operation.

    To answer your request, information regarding performance studies and acceptance criteria would need to be in a different section of a full 510(k) submission, typically in a "Performance Data" or "Clinical Data" section, which is not included here.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1