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510(k) Data Aggregation

    K Number
    K170446
    Device Name
    LT-300 SD Digital Video Colposcope
    Manufacturer
    Lutech Industries, Inc.
    Date Cleared
    2017-05-21

    (96 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LT-300 SD Digital Video Colposcope

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

    The LT-300 SD Digital Video Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for the LT-300 SD Digital Video Colposcope. The document is a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory compliance requirements but does not detail performance metrics, study designs, or ground truth establishment.

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