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510(k) Data Aggregation
K Number
K063066Device Name
AXIS-V MONOCHROME 5 MP DISPLAY
Manufacturer
Date Cleared
2007-08-03
(301 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL DISPLAY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AXIS-V 5MP Radiological Monochrome Medical Display is intended to be used to display and view digital images, including digital mammography, for review and analysis by trained medical practitioners.
Device Description
The AXIS-V 5MP Monochrome Display is a diagnostic display.
The AXIS-V 5MP Monochrome Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.
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K Number
K042353Device Name
AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS
Manufacturer
Date Cleared
2004-11-24
(86 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL DISPLAY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AXIS Radiology Monochrome Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The AXIS 5MP display is currently not cleared in the U.S. for use with Full Field Digital Mammography (FFDM). The AXIS 1MP, 2MP and 3MP displays are not intended for use with FFDM.
Device Description
The AXIS Monochrome Display is a diagnostic display. The AXIS Monochrome Display is a high resolution, Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images.
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K Number
K040310Device Name
NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS
Manufacturer
Date Cleared
2004-06-17
(129 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NATIONAL DISPLAY SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Nova Radiology Medical Displays are intended to be used to display and view digital images for review and analysis by trained medical practitioners. The Nova 5MP display is currently not cleared in the U.S. for use with Ful Field Digital Mammography (FFDM). The Nova 1MP, 2MP and 3MP displays are not intended for use with FFDM
Device Description
The Nova - Radiology Monochrome Display is a diagnostic display.
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