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510(k) Data Aggregation

    K Number
    K042634
    Device Name
    WIDE 1MP LCD MONITOR SYSTEM
    Manufacturer
    WIDE CORPORATION
    Date Cleared
    2004-10-08

    (11 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K023340
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    WIDE 1MP LCD Monitor System™ by WIDE Corporation is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. WIDE 1MP LCD Monitor System™ is not indicated for use with Mammographic images.

    Device Description

    The WIDE 1MP LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-ofthe-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

    The provided text is a 510(k) summary for the WIDE 1MP LCD Monitor System, which is a medical image display system. This document is a regulatory submission for market clearance and does not contain information about acceptance criteria or studies proving device performance for specific clinical tasks.

    The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and safety standards. It describes the device, its intended use (displaying and viewing digital medical images for review and analysis by trained medical practitioners, with an explicit exclusion for mammographic images), and compliance with various safety and EMC standards (UL2601-1/EN60601-1/IEC601-1, FCC Class B, CE, VCC, UL 950, cUL2601-1, CE Mark EMC/IEC = VCCI, CE, MIC FCC Class B).

    Therefore, I cannot provide the requested information from the given text as it does not contain:

    1. A table of acceptance criteria and reported device performance for a clinical task.
    2. Sample size used for a test set or data provenance.
    3. Number of experts or their qualifications.
    4. Adjudication method for a test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information about a standalone performance study.
    7. The type of ground truth used for a clinical study.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    This document is primarily concerned with regulatory clearance based on substantial equivalence, not a clinical performance study.

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