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510(k) Data Aggregation

    K Number
    K032960
    Device Name
    WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A
    Manufacturer
    WIDE CORPORATION
    Date Cleared
    2003-10-08

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K023322
    Predicate For
    K160355
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The WIDE 2MP TFT LCD Monitor System IF1902A ™s intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.

    Device Description

    The WIDE 2MP TFT LCD Monitor System IF1902A ™ is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.

    AI/ML Overview

    This document is a 510(k) summary for the WIDE 2MP TFT LCD Monitor System IF1902A™ and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

    The 510(k) summary primarily focuses on:

    • Device Description: A flat panel hi-resolution LCD monitor system for displaying digital medical images.
    • Intended Use: Displaying and viewing digital medical images for review and analysis by trained medical practitioners.
    • Technological Characteristics: An image display system consisting of computer software and components; does not contact the patient or control life-sustaining devices.
    • Predicate Device: CORNIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K023322).
    • Conclusion: The device is substantially equivalent to the predicate device.
    • Compliance: States manufacturing in accordance with voluntary and safety standards (UL, FCC, CE, VCC, etc.).

    There is no mention of:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any test set.
    3. Number or qualifications of experts used to establish ground truth.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    This document serves as a regulatory submission demonstrating substantial equivalence to a predicate device, rather than a clinical study report detailing performance against specific acceptance criteria.

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