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510(k) Data Aggregation

    K Number
    K992112
    Device Name
    SAMSUNG RAYPAX FILM DIGITIZER
    Manufacturer
    SAMSUNG SDS CO., LTD
    Date Cleared
    1999-09-09

    (79 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K974315
    Why did this record match?
    Device Name :

    SAMSUNG RAYPAX FILM DIGITIZER

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

    The Samsung RAYPAX™ Film Digitizer is a digitizer intended to convert medical images and data into digital signals. The digital data can be stored, communicated. processed and displayed within the system and or across computer networks at distributed locations.

    Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

    Device Description

    The Samsung Film Digitizer (FD) can be part of the RAYPAX PACS (Picture Archiving and Communication System), or can be a separate device for other manufacturer's PACS. It converts analog films to digitized images in the DICOM (Digital Imaging and Communications in Medicine) Standard 3 compatible files. In addition, FD supports a patient information search, an image information management, digitization, a DICOM file generation, a simple image processing, and DICOM file transferring to other components of the PACS.

    AI/ML Overview

    This document is a 510(k) summary for the Samsung RAYPAX™ Film Digitizer System. It describes the device's purpose, comparison to a predicate device, and confirms substantial equivalence to legally marketed devices. However, the provided text does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot fulfill your request for:

    • A table of acceptance criteria and reported device performance
    • Sample sizes used for the test set and data provenance
    • Number of experts and their qualifications for ground truth
    • Adjudication method for the test set
    • Multi-reader multi-case (MRMC) comparative effectiveness study details
    • Standalone performance study details
    • Type of ground truth used
    • Sample size for the training set
    • How ground truth for the training set was established

    The document focuses on regulatory compliance and the device's technical characteristics and indications for use, not on a detailed analysis of its performance or the studies conducted to prove its efficacy against specific acceptance criteria.

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