Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K141891
    Device Name
    MEDICAL LCD MONITOR
    Manufacturer
    Date Cleared
    2014-08-04

    (21 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOSTEC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical LCD Monitor is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
    Device Description
    The Medical LCD Monitor (Model: KT-D213V5E) is designed for the purpose of medical applications such as X-ray, radiology, MRI, endoscopy or mammography imaging display. The high-resolution LCD panel with a resolution of 2560 x 2048, combined with a high performance image processing controller, provides the users high-definition and high-quality medical image displays. The medical monitor complies with international EMC/ safety standards.
    Ask a Question

    Ask a specific question about this device

    K Number
    K123944
    Device Name
    KOSTEC MEDICAL GRADE LDC MONITORS
    Manufacturer
    Date Cleared
    2013-09-05

    (259 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOSTEC CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medical LCD Monitors are intended to be used in various kinds of medical image applications (excluding digital mammography) for which the device complies with the performance specifications of the system.
    Device Description
    The Medical LCD Monitors are designed for the purpose of medical applications such as X-ray, radiology, MRI or endoscopy imaging display. The high-resolution LCD panels with a resolution of 1280x1024, 1600x1200, 2048x1536 or 2560x2048, combined with a high-performance image processing controller, provides the users extremely high-definition and high-quality medical image displays. These medical monitors comply with international EMC/ safety standards.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1