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510(k) Data Aggregation

    K Number
    K080320
    Device Name
    PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
    Manufacturer
    NDS SURGICAL IMAGING
    Date Cleared
    2008-02-21

    (15 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K061927,K052344
    Why did this record match?
    Device Name :

    PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300

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

    The PrimeVue 21 inch 3MP Radiological Medical Display is intended to be used to display and view digital images for review and analysis by trained medical practitioners. However, This device must not be used in primary image diagnosis in mammography.

    Device Description

    The PrimeVue 21 inch 3MP Color Display is a diagnostic display. The PrimeVue 21 inch 3MP Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.

    AI/ML Overview

    This document indicates that the PrimeVue 21" 3MP Color Display is a diagnostic display intended for review and analysis of digital images by trained medical practitioners. It explicitly states that it must not be used in primary image diagnosis in mammography. The document is a 510(k) summary for the device.

    However, the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. It is a regulatory submission for premarket notification, establishing substantial equivalence to predicate devices. It discusses:

    • Manufacturer and device details: NDS Surgical Imaging, LLC, PrimeVue 21" 3MP Color Display.
    • Intended Use: Display and view digital images for review and analysis by trained medical practitioners (excluding primary image diagnosis in mammography).
    • Technological Characteristics: High-resolution Liquid Crystal Display (LCD) with electronic capabilities for review and analysis of high-resolution medical images.
    • Substantial Equivalence: Listing predicate devices (Coronis, Mdnc 3120 (Barco) K061927; RadiForce R31-C (Eizo Nanao) K052344).
    • Regulatory Classification: 21 CFR 892.2050/Procode 90LLZ (System, image processing, radiological).

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, or studies from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance studies against specific acceptance criteria.

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