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510(k) Data Aggregation

    K Number
    K122843
    Device Name
    MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR
    Manufacturer
    PRODIGY TECHNOLOGY CONSULTANT CO., LTD.
    Date Cleared
    2012-10-05

    (18 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K090215
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MD211G3 gray scale 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.

    MD211G3 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, MD211G3 is a 21.3" Monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study information for the NEC MD211G3 medical display, based on the provided text:

    Acceptance Criteria and Device Performance (Table)

    The device, MD211G3, is a medical LCD monitor. The primary "acceptance criteria" discussed are its performance specifications, which are benchmarked against those of its predicate device, the L218TL. The study aims to demonstrate substantial equivalence by meeting these comparable specifications.

    Acceptance Criteria (Predicate: L218TL)Reported Device Performance (MD211G3)
    Panel Size and Type: 21.3" TFT Monochrome LCD Monitor21.3" TFT Monochrome LCD Monitor
    Pixel Pitch: 0.212 mm x 0.212mm0.212 mm x 0.212mm
    Display Monochromes: 10-bit (1024 grey tones) with 3061 total colors10-bit (1024 grey tones) with 3061 total colors
    Viewing Angles (°) : H:176, V:176H:176, V:176
    Scanning Frequency (H, V): 31.5-95.4kHz, 30-85 Hz31.5-95.4kHz, 30-85 Hz
    Native Resolutions: 2048X15362048X1536
    Brightness: 400 cd/m² calibrated, 1450 cd/m² Max.400 cd/m² calibrated, 1450 cd/m² Max.
    Contrast Ratio: 900 : 1 (typical)900 : 1 (typical)
    DOT Clock: 162 MHz188 MHz
    Input Signals: Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital)Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital)
    Input Terminals: DVI-D, D-subDVI-D, D-sub
    USB (option) / StandardNo
    Active Display Size (H x V): Landscape: 433mmX325mm; Portrait: 325X433mmLandscape: 433mmX325mm; Portrait: 325X433mm
    Viewable Image Size: 540 mm (diagonal)540 mm (diagonal)
    Luminance Calibration: SoftwareSoftware
    Default Gamma: 1.8,2.0,2.2 DICOM part 14 + off, user1.8,2.0,2.2 DICOM part 14 user
    Power: AC100-240V, 50/60HzAC100-240V, 50-60Hz
    Power Consumption: 98W (Max)100W (Max)
    Power Save Mode:
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