LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K021903
    Device Name
    KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2002-07-10

    (30 days)

    Product Code
    IXA
    Regulation Number
    892.1850
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE

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

    KODAK X-OMAT Cassette/Leadless for Dental Use is a light-tight holder for intensifying screen and film, keeping them in close contact to provide a good radiographic image. This cassette can be used with dental x-ray imaging equipment that has an automatic exposure control (AEC) device.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a KODAK X-OMAT Cassette Leadless for Dental Use. This device is a physical radiographic film cassette and not an AI/ML powered medical device. Therefore, the questions related to AI/ML development, such as acceptance criteria based on algorithm performance, expert ground truth establishment, training/test sets, and comparative effectiveness studies with AI, are not applicable to this document.

    The document indicates that the device has been found substantially equivalent to legally marketed predicate devices. Its intended use is as a light-tight holder for an intensifying screen and film, used with dental x-ray imaging equipment and an automatic exposure control (AEC) device, to provide a good radiographic image.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1