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510(k) Data Aggregation
K Number
K112645Device Name
RADIFORCE LARGE MONITOR SYSTEM
Manufacturer
EIZO GMBH
Date Cleared
2011-09-22
(10 days)
Product Code
DXJ
Regulation Number
870.2450Why did this record match?
Applicant Name (Manufacturer) :
EIZO GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RadiForce Large Monitor System is intended to be used by health care professionals to integrate the video output from various commercially-available instruments commonly used in a medical procedure laboratory into a single video display.
Device Description
The system consists of the following components:
- LS560W Large Monitor Model No. 6GF6200-8A$## mandatory component
- LMM56800 Large Monitor Manager Model No. 6GF6020-1A$## mandatory component
- PDC0100 Analog DVI Converter -- Model No. 6GF6010-0B$## -- optional accessory
- PDS0800 DV! Splitter/Scaler Model No. 6GF6020-0AA00-#$$# optional accessory
- TDL3600 Transmission Link Model No. 6GF6010-#$$## optional accessory
- CID1000P Control Interface Device 6GF6550-2H$## optional accessory
- Cabinet optional accessory
where "$" signifies a letter from A to Z, and "#" a number from 0 to 9.
The RadiForce Large Monitor System is a large color flat panel monitor for viewing images derived from several video sources on a single display and to rearrange these images to the situational requirements of the user. To appreciate all of the advantages of the large widescreen monitor, the data has to be collected from the various sources and prepared for variable viewing. This is handled by the mandatory "Large Monitor Manager" ("LMM"). In some reports or references you will find the "LMM" being called "MDM" for "Multi Display Manager" (customer specific product name). The various video sources are being bundled using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines.
Control of the video sources can also be accomplished using Eizo's Control Interface Device CID as optional part of the system or any other standard browser compatible operator console.
The RadiForce Large Monitor System uses a color LCD panel employing Multi-domain Vertical Alignment (MVA) technology to allow wide viewing angles. It has a resolution of 3840 x 2160 pixels and is used in landscape mode.
The various video sources from medical and other devices are being collected using the Large Monitor Manager and from there being fed into the Large Display via two DVI lines. An optional external operator console (Control Interface Device CID) can be used as optional part of the system to rearrange pictures from the regarding sources or switch between numerous presets according to specific user's needs.
The RadiForce Large Monitor System may be offered in different housing colors and with different logos. These are cosmetic differences and of no effect on the function and performance of the system.
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K Number
K103724Device Name
10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)
Manufacturer
EIZO GMBH
Date Cleared
2011-06-08
(169 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EIZO GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 10MP Grayscale Flat Panel Display (GX1030) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Device Description
The 6GF6201-8CS## is a diagnostic 10MP gravscale flat panel display for viewing medical images. With the callbrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DV! graphic controller boards. The display is used in dual-head configuration.
The 10MP Grayscale Flat Panel Display uses a monochrome LCD panel employing in-plane switching (IPS) technology to allow wide viewing angles. It has a resolution of 4096 x 2560 pixels and is used in landscape mode. The display uses backlight sensor to automatically stabilize the set luminance levels of the CCFL backlight over time. It also sports an integrated front sensor for independent grayscale verification. The factory calibrated gamma response is stored in five lookup tables located in the display, allowing users to adapt the display to local lighting conditions and ensuring that the display function is DICOM compliant regardless of the display controller used.
The 10MP Grayscale Flat Panel Display may be offerent housing colors and with different logos. These cosmetic differences are reflected in the designators represented by the characters "$" and "#" included in the model trade name 6GF6201-8C$#, where $ represents a letter between A and Z, and # is a number between 0 and 9.
The 10MP Grayscale Flat Panel Display uses the same LCD panel from the same manufactorer as the predicate device and employs CCFL backlight technology. It is equipped with two integrated luminance sensors, one mounted rear center and a built in front sensor, as included with the Coronis Fusion 10MP.
The housing, stand, electronics and the integrated luminance sensors are not the same as those components used in the predicate devices. The overall design of the 6GF6201-8C$## was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and inhouse. Additionally, EIZO GmbH performed a range of system and performance tests to ensure that the 10MP Grayscale Flat Panel Display performed in accordance with its specifications.
While the predicate device is equipped with a proprietary high speed display controller, the 6GF6201-8CS## was designed to receive and display images from standard, commercial DVI display controllers.
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K Number
K081357Device Name
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)
Manufacturer
EIZO GMBH
Date Cleared
2008-09-05
(114 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
EIZO GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 5MP Grayscale Flat Panel Display is intended to be used in displaying and viewing digital images, including digital mammography, for review, analysis and diagnosis by trained medical practitioners.
Device Description
The 6GF6201-5C$2# is a diagnostic 5MP grayscale flat panel display for viewing medical images. With the calibrated gamma response stored in five internal lookup tables, the display is suitable for use with a wide range of DVI graphic controller boards. The display can be used in single-head or multi-head configurations.
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