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510(k) Data Aggregation

    K Number
    K021072
    Device Name
    FILMSAVER, NT VERSION 5.03
    Manufacturer
    AMERICAN MEDICAL RESOURCES, LTD. (AMR)
    Date Cleared
    2002-06-06

    (65 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FilmSaver NT Version 5.03 software is intended to reduce the total film consumption of a CT scanner, MRI, etc. by reducing the area needed for the diagnostic image. The device uses propriety software algorithms to receive, process, and send analog or digital radiological images. The FilmSaver product is designed to interface with industry standard radiology equipment.

    Device Description

    FilmSaver NT Version 5.03 software

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "FilmSaver NT Version 5.03 FilmSaver Software." It does not contain any information regarding acceptance criteria, study details, or performance results of the device.

    The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to. The "Indications for Use Statement" describes the intended purpose of the software, which is to reduce film consumption by reducing the area needed for diagnostic images from CT, MRI, etc., using proprietary software algorithms to receive, process, and send radiological images and interface with standard radiology equipment.

    Therefore, I cannot provide the requested information as it is not present in the given text.

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