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510(k) Data Aggregation
K Number
K161057Device Name
Diagnostic Imaging Color LCD Monitor
Manufacturer
Date Cleared
2016-05-13
(29 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEC DISPLAY SOLUTIONS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MDC212C2 Color displays are intended to be used for displaying of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used in conjunction with NEC approved display controllers.
MDC212C2 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 IEC 60601-1-1 certified equipment.
Device Description
Diagnostic Imaging Color LCD Monitor, Model MDC212C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1600*1200p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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K Number
K150145Device Name
MD322C8 31.5 Diagnostic Imaging LCD Monitor
Manufacturer
Date Cleared
2015-02-06
(15 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEC DISPLAY SOLUTIONS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MD322C8 color 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. MD322C8 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, MD322C8 is a 31.5" Color LCD monitor that displays image for medical use. It provides 3840*2160p resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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K Number
K142951Device Name
MD210C3 21.3 Diagnostic Imaging LCD Monitor
Manufacturer
Date Cleared
2014-12-10
(61 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NEC DISPLAY SOLUTIONS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MD210C3 color 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.
MD210C3 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, MD210C3 is a 21.3" Color 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.
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