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510(k) Data Aggregation

    K Number
    K001445
    Device Name
    SMILIE PC
    Manufacturer
    JULIE ALLIANCE
    Date Cleared
    2000-07-26

    (79 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    JULIE ALLIANCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K990002
    Device Name
    QUICKRAY DSX 730
    Manufacturer
    JULIE ALLIANCE
    Date Cleared
    1999-04-01

    (87 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    JULIE ALLIANCE

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

    The QuickRay DSX 730 sensor device and related components is used to provide instant images of x-rayed human oral tissue and teeth without the use of conventional film.

    Device Description

    The QuickRay DSX 730 sensor device and related components. This is acheived by using the conventional x-ray tube, but by placing an electronic sensor, instead of film, inside the patients mouth. The sensor, and by means of the imaging acquisition software provide automatically captures the images into a computer for viewing, storage and printing. Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zooming, pseudo coloration, image inversion, histograms, etc.

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for the QuickRay DSX 730 device. This device is a digital X-ray sensor for capturing images of human oral tissue and teeth, replacing conventional film.

    Unfortunately, neither of these documents contains information regarding acceptance criteria or a study proving the device meets acceptance criteria. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device, indicating it has met regulatory requirements for market clearance, not necessarily performance-based acceptance criteria from a specific study.

    Therefore, I am unable to provide the requested information based on the input text. The documents do not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts used to establish ground truth or their qualifications.
    4. Adjudication method.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    6. Information about a standalone (algorithm only) performance study.
    7. The type of ground truth used.
    8. The sample size for the training set.
    9. How the ground truth for the training set was established.
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