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QUBYX Receives FDA 510(k) Clearance for the DELL UltraSharp U3011 with PerfectLum Bundle
DELL UltraSharp U3011 displays in bundle with QUBYX PerfectLum calibration software have received the FDA 510(k) clearance that officially certifies the bundle to be used in medical imaging industry
"We are very pleased to have now not only European CE Mark for PerfectLum software, but also the FDA clearance for the DELL 4 MP display and PerfectLum bundle," says Marc Leppla, Director of QUBYX. "The FDA clearance allows the bundle to officially enter the US and international markets as a medical device. Moreover, it will ensure confidence in quality and safety of the device for healthcare facilities, relying on FDA 510(k) clearance when purchasing medical monitors."
The DELL UltraSharp U3011 is a 30-inch 4MP display with a resolution of 2560x1600 pixels, a typical brightness of 370 cd/m2 and IPS (in-plane switching) panel technology. The display is designed to provide more consistent colors, a brighter picture from different angles and brilliance across the color spectrum. It allows the user to experience lifelike visuals at 117% (CIE 1976) typical color gamut and to see more detail in grayscales. Multiple connectivity thanks to DisplayPort, two HDMI 1.3 and two DVI-D connectors is also one of UltraSharp U3011 remarkable features.
The DICOM calibration software PerfectLum 3.0 allows to use this high quality display for viewing of medical images and diagnostics. The UltraSharp monitor in bundle with PerfectLum is delivered calibrated to DICOM GSDF part 14 standard. Moreover, the software allows performing DICOM, Gamma and CIE L* hardware re-calibrations using the 10 Bit LUT (Look Up Table) of the display, as well as DICOM, AAPM TG18, DIN 6868-57 conformance tests, verification of white level, luminance level and display uniformity. Such PerfectLum features as calibration of multiple displays, connected to one workstation, and remote management of multiple workstations from one location will be beneficial to networks of healthcare facilities and telemedicine.
The FDA certification for the DELL UltraSharp-QUBYX PerfectLum bundle proves the companies' commitment to medical imaging field. It also provides evidence of the concept, that commercial displays can be calibrated to meet the highest demands of medical industry and successfully utilized for diagnostics and reviewing of medical images.
DELL Inc. is an American multinational information technology corporation based in Round Rock, Texas, United States, that develops, sells and supports computers and related products and services. Bearing the name of its founder, Michael Dell, the company is one of the largest technological corporations in the world. Today, Dell connects with more than 5.4 million customers every day - by the phone, in person, on the company website and, increasingly, through social networking sites. To read more about DELL, please visit www.dell.com
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