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510(k) Data Aggregation

    K Number
    K160347
    Device Name
    Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
    Manufacturer
    QINGDAO HISENSE MEDICAL EQUIPMENT CO.,LTD
    Date Cleared
    2016-03-03

    (24 days)

    Product Code
    PGY
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K091172,K131246,K062131
    Why did this record match?
    Device Name :

    Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

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

    The 2MP/3MP LCD Monitor (HMD2G21) is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

    The 5MP LCD Monitor (HMD5G21) is intended to be used in displaying digital images for review and analysis by trained medical practitioners, including digital mammography.

    Device Description

    The 2MP/3MP/5MP LCD Monitor (HMD2G21/HMD3G21) is a display system for medical viewing, with high resolution 1600x1200(HMD2G21)/2048 x 1536(HMD3G21)/ 2560 x 2048(HMD5G21), built-in brightness stabilization circuit, front sensor and ambient light sensor, stable brightness and persistent calibration can be guaranteed. The display can support both landscape and portrait mode. The antiglare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

    AI/ML Overview

    The document describes a 510(k) premarket notification for several Hisense LCD monitor models (HMD2G21, HMD3G21, HMD5G21). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly defined by compliance with IEC 60601-1 and IEC 60601-1-2 standards, and by demonstrating performance comparable to or better than the predicate devices. The study detailed below focuses on comparing the Hisense monitors' specifications to those of their respective predicate devices.

    Here's a consolidated table comparing the proposed Hisense devices (HMD2G21, HMD3G21, HMD5G21) with their identified predicate devices (BARCO Nio 2MP, Nio 3MP, Nio 5MP) based on the provided "General Comparison" tables.

    FeatureAcceptance Criteria (Predicate Device Performance)Hisense HMD2G21 PerformanceHisense HMD3G21 PerformanceHisense HMD5G21 Performance
    Intended UseDisplaying and viewing digital images (excluding digital mammography for 2MP/3MP; including digital mammography for 5MP) for review and analysis by trained medical practitioners.Same as predicateSame as predicateSame as predicate
    Panel Size & Type21.3", TFT LCD display (2MP, 5MP); 21.3", TFT LCD display (3MP)21.3", TFT LCD display21.2", IPS-NEO, antiglare21.3", IPS-NEO, antiglare
    Pixel Pitch0.27 mm (2MP); 0.2115 mm (3MP); 0.165 mm (5MP)0.27 mm0.21075 mm0.165 mm
    Native Resolutions1600x1200 (2MP); 2048x1536 (3MP); 2560x2048 (5MP)1600x12002048x15362560x2048
    Brightness1650 cd/m2 (2MP); 800 cd/m2 (3MP); 700 cd/m2 (5MP)1900 cd/m21700 cd/m21200 cd/m2
    Contrast Ratio850:1 (2MP); 1700:1 (3MP); 800:1 (5MP)1400:11400:11200:1
    Network InterfaceUSB (1 Up, 2 Downstream)USB (1 Up, 2 Downstream)USB (1 Up, 2 Downstream)USB (1 Up, 2 Downstream)
    Active Display Size (HxV)432mm x 324mm (2MP); 433mm x 325mm (3MP); 422mm x 338mm (5MP)432.0mm x 324.0mm431.6mm x 323.7mm422.4mm x 337.9mm
    Operating Temp.0°C ~ 35°C (2MP); 0°C ~ 40°C (3MP, 5MP)0°C ~ 40°C0°C ~ 40°C0°C ~ 40°C
    Transport/Storage Temp.-20°C ~ 60°C-20°C ~ 60°C-20°C ~ 60°C-20°C ~ 60°C
    Operating Humidity8% ~ 80% (non-condensing)20% ~ 80%20% ~ 80%20% ~ 80%
    Transport/Storage Humidity5% ~ 85% (2MP); 5% ~ 95% (3MP, 5MP)10% ~ 90%10% ~ 90%10% ~ 90%
    Power Capacity
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