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510(k) Data Aggregation

    K Number
    K032555
    Device Name
    3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2004-02-26

    (191 days)

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

    3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316

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

    3M Color Medical Flat Panel Display, CCL316, is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging application by physicians. It is not meant to be used for digital mammography.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for the 3M Color Medical Flat Panel Display, CCL316. It indicates that the device is substantially equivalent to a legally marketed predicate device.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the specific details requested in your prompt.

    The letter solely grants permission to market the device based on a determination of substantial equivalence, and it specifies the indications for use. It does not include the detailed technical study information you've asked for.

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