QUBYX PerfectLum Calibration and QA Software Bundled with Dell U3014 4MP Display Receives FDA 510(k) Clearance for Diagnostic Viewing
Wilmington, DE, July 14, 2014 (Newswire.com) - QUBYX receives an FDA clearance for PerfectLum in bundle with DELL U3014
07/10/2014, Wilmington, DE, USA - QUBYX, an expert in medical imaging and color calibration fields, has announced that the bundle of PerfectLum DICOM calibration application and Dell UltraSharp U3014 has received the Food & Drug Administration 510(k) market clearance. Cleared by the FDA, PerfectLum and Dell U3014 bundle will now be marketed in the US and other countries as a display for viewing medical images, review and analysis by trained medical practitioners.
A cost-efficient solution for any hospital budget
“We are glad to obtain the FDA clearance, as it will provide confidence in the quality and safety of the product for medical care centers that rely on FDA 510(k) when purchasing medical equipment,” says Marc Leppla, Director and CTO of QUBYX. “This is especially important for the developing markets, where the growing demand for quality healthcare is combined with lower hospital budgets.”
Dell Ultrasharp U3014 overview
Dell U3014 is a 30” 4MP primary display with IPS panel, extremely stable LED backlight and a resolution of 2560x1600 pixel. With U3014 the user can see more detail in gray shades and view lifelike images at 120% typical color gamut and color depth of 1.07 billion colors enabled by the 12-bit internal processing and a 14-bit look-up table (LUT).
PerfectLum overview
QUBYX PerfectLum DICOM calibration software enhances the performance of displays in accordance with medical imaging requirements, including NEMA DICOM part 14 GSDF. PerfectLum Suite not only calibrates displays, but also performs acceptance and constancy tests to verify that the display conforms to such regulations as AAPM TG18, DIN 6868-57, DIN 6868-157, JESRA X-0093, IEC 62563-1 and the New York state Primary Diagnostic Monitor (PDM) Quality Assurance Program.
The perfect combination
Bundled with PerfectLum, the U3014 can be calibrated to DICOM, which makes it usable as a diagnostic display. The application allows radiology practitioners to perform hardware re-calibrations, with the software using the 14-bit LUT of the monitor. Moreover, PerfectLum will perform acceptance and constancy tests as required by international standards, to verify that Dell U3014 remains within the quality requirements. With the free Remote display management system, that helps to calibrate and control all displays from one location, PerfectLum & Dell U3014 is an optimal display solution for large healthcare centers and hospital networks.