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510(k) Data Aggregation

    K Number
    K990087
    Device Name
    DMD DIGITAL X-RAY SYSTEM
    Manufacturer
    DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC.
    Date Cleared
    1999-05-13

    (122 days)

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

    DMD DIGITAL X-RAY SYSTEM

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

    The DMD Digital X-ray is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA clearance letter for a device called "DMD Digital X-Ray System" and its indications for use. It does not include acceptance criteria, study details, or performance data as requested in your prompt. Therefore, I cannot generate the specific information about acceptance criteria and study proving device performance based on the given input.

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