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510(k) Data Aggregation

    K Number
    K983057
    Device Name
    ORTHOPHOS 5/PLUS/CD
    Manufacturer
    SIRONA DENTAL SYSTEMS GMBH
    Date Cleared
    1998-10-22

    (51 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K013650,K040382
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Orthophos 5/PLUS/CD is an extraoral X-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging, teleradiography, and transverse slice imaging.

    Device Description

    The Orthophos 5/PLUS/CD is an extraoral X-ray system.

    AI/ML Overview

    This document is a marketing clearance letter from the FDA for the Orthophos 5/PLUS/CD X-ray system. It does not contain any information about acceptance criteria or a study proving device performance. Therefore, I cannot generate the requested information based on the provided text.

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