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510(k) Data Aggregation
K Number
K101796Device Name
PACSMATE MMD-5201M MONITOR
Manufacturer
Date Cleared
2010-07-15
(17 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IEI TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to be used as a tool in displaying and viewing digital images, including digital mammography system for view and analyses by trained medical practitioner.
Device Description
The MMD-5201M LCD monitors are displays for medical use. MMD-5210M provides 5 mega pixel resolution and 766 grayscales per pixel display. The display device is complied with the standard ISO13406-2 to conform to the requirement of the mammography display system.
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K Number
K091687Device Name
PACSMATE, MODEL MMD-4300C/MMD-4300CX
Manufacturer
Date Cleared
2009-07-07
(27 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IEI TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PACSmate MMD=4300C/4300CX is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. PACSmate MMD-4300C/4300CX does not support the display of mammography images for diagnosis.
Device Description
The PACSmate MMD-4300C/4300CX is a 30" monochrome/color LCD display for medical image viewing.4 Mega pixel medical grade LCD monitor with high resolutions.
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K Number
K082496Device Name
PACSMATE MMD-3213M MONITOR
Manufacturer
Date Cleared
2008-09-09
(11 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IEI TECHNOLOGY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to be used to as a tool in displaying and viewing digital images view and analyses by trained medical practitioner. The device is not specified for digital mammography system.
Device Description
The MMD-3213M LCD monitors are displays for medical image viewing. MMD-3213M provides 3 mega pixel resolution. The PACSmate MMD-3213M is a high performance, 3 Megapixel medical grade monochrome LCD monitors designed for exacting needs for diagnostics professionals that provide clear and sharp images with resolutions of up to 2048 x 1536 pixels, 600 cd/m2 brightness and 700:1 contrast ratio, making it ideal for diagnosing detailed medical graphics. Also uses a DVI digital interface offering compatibility with the latest digital standards.
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