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510(k) Data Aggregation

    K Number
    K083917
    Device Name
    X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
    Manufacturer
    SUNI MEDICAL IMAGING, INC.
    Date Cleared
    2009-06-02

    (154 days)

    Product Code
    OAS,LLZ,MUH
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K082350
    Why did this record match?
    Device Name :

    X-RAY, TOMOGRAPHY, COMPUTED, DENTAL

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

    The Suni3D is a computed tomography x-ray system, which is a diagnostic x-ray system intended to produce panoramic, cephalometric, and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Suni3D computed tomography x-ray system, confirming its substantial equivalence to a predicate device. It specifies the intended use and regulatory information but does not detail performance metrics, study designs, or ground truth establishment.

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