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510(k) Data Aggregation

    K Number
    K051464
    Device Name
    PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
    Manufacturer
    PLANMECA OY
    Date Cleared
    2005-06-24

    (21 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K011619,K000163
    Why did this record match?
    Device Name :

    PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)

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

    Planmeca Promax, panoramic x-ray imaging system with Cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil the different diagnostic needs. In digital configuration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.

    Device Description

    Planmeca Promax is a conventional panoramic x-ray system utilizing either films and intensifying screens or digital imaging. The product can be equipped with a cephalostat. The product modification includes a new DEC (Dynamic Exposure Control) system, which is designed to be used in digital imaging, in both panoramic and cephalostat modes, and replaces the old AEC system used.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Planmeca Promax with DEC (Dynamic Exposure Control), a panoramic x-ray system with a cephalostat, dated May 27, 2005. This summary focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new DEC system.

    Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, ground truth methods, or comparative effectiveness.

    The document primarily states:

    • Substantial Equivalence: The manufacturer considers the product modification, including the new DEC system, to be substantially equivalent in design and function to the Planmeca Promax (#K011619) and PM 2002 Proline with AEC (#K000163).
    • Safety and Effectiveness: It claims that "Planmeca Promax with DEC is as safe and effective as the predicate devices."

    Without a separate study report detailing performance metrics for the DEC system, it's impossible to fill out the requested table and answer the specific questions about acceptance criteria and study results. This 510(k) summary is a regulatory filing asserting equivalence based on modification, not a performance study report.

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