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510(k) Data Aggregation

    K Number
    K030272
    Device Name
    FLAT PANEL DISPLAY, ME183L
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2003-04-25

    (88 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K012099
    Why did this record match?
    Reference Devices :

    K012099

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

    ME183L Medical Display is intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

    Device Description

    ME183L is a display for medical use. ME 183L is a monochrome LCD display.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical display device (ME183L) and its substantial equivalence to a predicate device (Totoku ME311L). However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for performance evaluation.

    The document focuses on:

    • Device Identification: Company, correspondent, submission date, trade name, common name.
    • Classification: Medical display classified as Class I or II per 21 CFR 890.2050.
    • Predicate Device: Totoku ME311L (K012099).
    • Device Description: ME183L is a monochrome LCD display.
    • Intended Use: For use with PACS for medical imaging applications by physicians.
    • Compliance: Adherence to various medical safety and EMC standards (UL2601-1, CSA No. 601-1, MDD/CE, EN60601-1, IEC60601-1, EN60601-1-2, FCC-B, VCCI-B).
    • Comparison to Predicate: A table comparing specifications like display area, input signal, maximum pixels, scanning frequency, maximum image clock, maximum brightness, brightness calibration, serial communication, agency standards, and dimensions/weight between the ME311L and ME183L is provided.

    Therefore, I cannot fulfill your request for: Acceptance Criteria, Study Details, Sample Sizes, Ground Truth, Expert Qualifications, Adjudication Methods, MRMC Study, or Standalone Performance. This information is typically part of a detailed clinical or performance study report, which is not present in this 510(k) summary.

    The comparison table provided only lists the specifications of the new device (ME183L) and the predicate device (ME311L) to demonstrate technological equivalence, not a performance study against specific acceptance criteria.

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