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510(k) Data Aggregation
K Number
K141891Device Name
MEDICAL LCD MONITOR
Manufacturer
Date Cleared
2014-08-04
(21 days)
Product Code
Regulation Number
892.2050Why 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.
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K Number
K123944Device Name
KOSTEC MEDICAL GRADE LDC MONITORS
Manufacturer
Date Cleared
2013-09-05
(259 days)
Product Code
Regulation Number
892.2050Why 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.
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