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This product is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.

RadiForce GX540 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX540" such as "GX540-CLAR", a model whose backlight is Clear Base with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX540 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX540.

This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

The RadiForce RX440 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2,560 x 1,600 pixels (4MP) with a pixel pitch of 0.2505 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX440" such as "RX440-AR", a model with an Anti-Reflective coating on the screen surface although the hardware design, components and labeling remain unchanged. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX440 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce RX440.

The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

The RadiForce RX840-MG is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. With the matrix size (or resolution) of 4.096 x 2.160 pixels (8MP), the RX840-MG is an alternate replacement for traditional dual head 5MP display installations.

The RadiForce RX340 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

The RadiForce RX340 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.21075 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX340 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX340.

The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not for use for screening or diagnostic mammography.

The RadiForce MX270W is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2560 x 1440 pixels (3.7MP) with a pixel pitch of 0.233 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including MX270W based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce MX270W.

The RadiForce GX240 is intended to be used in displaying and viewing digital images by trained medical practitioners. The RadiForce GX240 does not support the display of mammography images for diagnosis.

The RadiForce GX240 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,200 x 1,600 pixels (2MP) with a pixel pitch of 0.270 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX240" such as "GX240-CL", a model whose backlight is Clear Base (one of tints) although the hardware design, components and labeling remain unchanged. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX240 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX240.

The RadiForce GX340 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.

The RadiForce GX340 is a monochrome LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "GX340" such as "GX340-CL", a model whose backlight is Clear Base (one of tints) . RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX340 based on several OC guidelines. The RadiCS and its subset. RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX340.

The RadiForce RX240 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

The RadiForce RX240 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1200 x 1600 pixels (2MP) with a pixel pitch of 0.270 mm. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX240 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX240.

The RadiForce RX840 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

The RadiForce RX840 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 4096 x 2160 pixels (8MP), spacious enough to display e.g. two 3MP radiological images and other clinical information side by side without obtrusive bezels. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX840" such as "RX840-AR", a model with an Anti-Reflective coating. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX840 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840.

The RadiForce GX530 is intended to be used in displaying digital images including those of digital mammography for review and analysis by trained medical practitioners.

The RadiForce GX530 is a 5MP monochrome LCD monitor for viewing medical images including those of digital mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles. The matrix size (or resolution) of the panel is 2560 x 2048 pixel pitch is 0.165 mm, both of which are the same as those of displays approved so far for digital mammography including the predicate device, RadiForce GS10. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF) and a specific luminance range, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including GX530 based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce GX530.