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510(k) Data Aggregation

    K Number
    K982661
    Device Name
    CDR - PAN MODEL 4700
    Manufacturer
    SCHICK TECHNOLOGIES, INC.
    Date Cleared
    1998-12-11

    (134 days)

    Product Code
    MQB,MUH
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CDR - PAN MODEL 4700

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

    The CDR-PAN Panoramic Dental Digital Imager is indicated for use in acquiring radiographic images at the dento-maxillofacial region. It is intended to replace radiographic film/screen systems in panoramic dental diagnostic procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the CDR-PAN Model 4700, an extraoral source x-ray system. The document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The information provided is insufficient to answer the request.

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