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510(k) Data Aggregation

    K Number
    K024285
    Device Name
    A/T X-RAY 70
    Manufacturer
    AIR TECHNIQUES, INC.
    Date Cleared
    2003-04-16

    (114 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    A/T X-RAY 70

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

    The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors) for the purpose of radiographic examination and diagnosis of diseases of the teeth.

    Device Description

    The A/T X-Ray 70 is an extra oral device designed to expose intra oral x-ray recording media (film, plates, sensors).

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental X-ray device and an associated "Statement of Indications for Use." It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

    Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document is purely administrative pertaining to regulatory clearance.

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