FDA Approves Dell UP3216Q Monitor and PerfectLum for Diagnostic Use
Qubyx PerfectLum, the software for calibration and consistent performance of medical workstations, bundled with the premium 8 MP monitor Dell UP3216Q, has received the FDA 510(k) market clearance for displaying and viewing of medical images, as well as for review and analysis by trained medical practitioners.
- (1888PressRelease) August 23, 2016 - Qubyx Software Technologies Inc., the U.S. software maker, announced that the U.S. Food and Drug Administration has issued 510(k) clearance for the Dell Ultrasharp UP3216Q monitor and PerfectLum, the company's calibration and quality assurance software for medical purposes.
Dell UltraSharp UP3216Q is a 31.5 -inch 8MP medical monitor with a resolution of 3840 х 2160 pixels, a typical brightness of 300 cd/m2 and IPS (in-plane switching) panel technology. The monitor is designed to provide consistent colors, a bright picture from different angles and brilliance across the color spectrum. In order to improve colour accuracy further, we bundled the monitor with PerfectLum application which enables DICOM conformance and luminance checks, as well as acceptance and constancy tests. The bundle has received the FDA 510 (k) clearance as a medical device and is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
"We are pleased to have this FDA clearance completed, as it proves our commitment to medical imaging field." - says Mrs. Nathalie Richart, Director of Business Development at Qubyx. "Offered for only $1680, the Dell UP3216Q & PerfectLum bundle lets hospitals make considerable cost savings when purchasing clinical review displays."
What is PerfectLum?
The DICOM calibration and quality assurance software PerfectLum allows performing DICOM, Gamma and CIE L* calibrations, conformance tests, verification of white level and luminance level, and quality assurance tests in accordance with AAPM TG18, DIN 6868-57,DIN 6868-157, JESRA X-0093, IEC 62563-1, NY PDM, NYC PDM, and ACR regulations. PerfectLum prepares detailed reports for every operation it performs. With its Remote management feature, allowing to maintain multiple workstations from one location, PerfectLum is an asset for networks of healthcare facilities and telemedicine.
* Please note, a special measuring device - colorimeter is necessary for the calibration process. However, it is not included with the bundle. It can be added to your order per request in case you have no measuring device.
* The monitor is not to be used to read or review mammography
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