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510(k) Data Aggregation

    K Number
    K033419
    Device Name
    STV PRO 2
    Manufacturer
    TROPHY RADIOLOGIE
    Date Cleared
    2004-02-02

    (98 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STV PRO 2

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

    The STV PRO 2 is:

    • a camera which delivers color images of the oral cavity,
    • a communication tool which allows the patient and dentist to view the patient's oral cavity
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the STV PRO 2 dental operative unit and accessories. It confirms the device's substantial equivalence to a legally marketed predicate device.

    The document discusses the regulatory aspects of the device, its classification, and requirements for marketing. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the manufacturer's 510(k) submission, but they are not present in the FDA's response letter provided.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information regarding the study.

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