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510(k) Data Aggregation

    K Number
    K142719
    Device Name
    E-App
    Manufacturer
    GC MEDTECH, LLC
    Date Cleared
    2015-05-20

    (239 days)

    Product Code
    JAQ
    Regulation Number
    892.5700
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    E-App

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

    The GC Medtech Esophageal Applicator (E-App) is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a high dose rate after-loader.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) premarket notification letter from the FDA to GC Medtech, LLC, for their E-App device. This document primarily focuses on the FDA's decision regarding substantial equivalence and regulatory compliance.

    The document does not contain any information about:

    • Acceptance criteria for device performance.
    • Any study details, including sample sizes, data provenance, expert qualifications, or adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used or how it was established for training or testing sets.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.

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