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510(k) Data Aggregation

    K Number
    K132587
    Device Name
    MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR
    Manufacturer
    NED DISPLAY SOLUTIONS LTD.
    Date Cleared
    2013-08-29

    (13 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K083907
    Predicate For
    K133708
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MD242C2 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers. MD242C2 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

    Device Description

    Medical Display, MD242C2 is a 24.1" Color LCD monitor that displays image for medical use, It provides 2.3 mega pixel (1920*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical display monitor (MD242C2 24.1" Diagnostic Imaging LCD monitor). This document focuses on demonstrating substantial equivalence to a predicate device L217TG TFT Color LCD Monitor rather than conducting a clinical study to prove performance against specific acceptance criteria for a new medical algorithm or diagnostic tool.

    Therefore, many of the requested sections about clinical study design, sample sizes, expert involvement, and ground truth establishment are not applicable. The device in question is a display monitor, not an AI-powered diagnostic device or an algorithm that interprets medical images.

    Here's an attempt to answer the questions based only on the provided text, highlighting where information is not applicable:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study assessing diagnostic performance. Instead, it compares the technical specifications and intended use of the new device (MD242C2) to a legally marketed predicate device (L217TG) to demonstrate substantial equivalence.

    The "performance" is reported as its technical specifications, which are implicitly accepted if they are substantially equivalent to the predicate device.

    ItemsPredicate Device (L217TG) PerformanceApplicant Device (MD242C2) PerformanceImplicit Acceptance Criteria (Substantial Equivalence)
    Panel Size and Type21.3" TFT Color LCD Monitor24.1" TFT Color LCD MonitorComparable size and type for diagnostic imaging. New device is larger, but still within acceptable medical monitor range.
    Pixel Pitch0.270 mm x 0.270 mm0.270 mm x 0.270mmIdentical
    Display Color16,777,2161,073,741,824Improved (more colors), therefore acceptable
    Viewing Angles (°) (H,V)H:176, V:176H:178, V:178Improved, therefore acceptable
    Scanning Freq. (H,V)31.5-91.1kHz, 50-85 Hz31.5-93.8, 118.4kHz, 50-85 HzComparable/Improved
    Native Resolutions1600X12001920X1200Improved (higher resolution), therefore acceptable
    Brightness400 cd/m² calibrated, 850 cd/m² Max.180 cd/m² calibrated, 350 cd/m² Max.Calibrated brightness is lower, but still within specifications for diagnostic monitors (DICOM conformance is mentioned). Max brightness is lower. This is deemed acceptable as the device still conforms to relevant standards (e.g., DICOM part 14, DIN V 6868-57).
    Contrast Ratio1050 : 1 (typical)1000 : 1 (typical)Comparable
    DOT Clock162 MHz202.5 MHz (Max) (Analog), 162 MHz (Max) (Digital)Comparable/Improved
    Input Signals/TerminalsD-sub analog VGA, DVI-I (x2)DVI port, Display port, HDMI portDifferent, but modern and functionally equivalent/improved for connecting to display controllers.
    Active Display Size (H x V)Landscape: 432mmX324mm, Portrait: 324X432mmLandscape: 518.4mmX324mm, Portrait: 324X518.4mmIncreased, consistent with larger panel size, therefore acceptable.
    Viewable Image Size (diagonal)540 mm540 mmIdentical
    Luminance CalibrationSoftwareSoftwareIdentical
    Default GammaDICOM part 14 + off, etc.DICOM part 14Simplified to primarily DICOM part 14, but still meeting the critical standard.
    PowerAC100-240V, 50/60HzAC100-240V, 50/60HzIdentical
    Power Consumption100W (Max)38.4W (Max)Improved (lower consumption), therefore acceptable
    Power Save Mode
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