QUBYX Receives FDA 510 (k) clearance for a PerfectLum 4.0 and Apple 5K iMac software Bundle.
QUBYX Medical Solutions Inc. has announced FDA 510(k) clearance to bundle QUBYX PerfectLum with the Apple iMac 27” for a medical device upgrade.
Wilmington, DE, USA, June 24, 2020
QUBYX Medical Solution Inc., announced U.S. Food and Drug Administration clearance to bundle PerfectLum4 with the Apple 5K iMac 27”.
With this move, QUBYX strengthens its presence in the important diagnostic, teleradiology, and medical display market with a product that will likely under-price most existing FDA approved medical monitors. This is the first Apple iMac diagnostic medical display to be offered to healthcare institutions.
QUBYX’s PerfectLum is a multi-platform, multilingual, full-featured, calibration system with remote management that significantly enhances display performance in all circumstances. More importantly, PerfectLum provides up-to-date industry-specific compliance with medical imaging
standards (Including NEMA DICOM part 14 GSDF). This is the first time that such industry-specific standards have been achievable on a Mac.
Apple has a long history of premium performance monitors and the current models are no exception, offering impressive specs – 500nits brightness, 5K with 5120 x 2880 resolution, P3 (wide color) and a billion colors.
QUBYX’s PerfectLum is a multi-platform, multilingual, full-featured quality assurance tool, with a remote management and cloud solution, that not only calibrates a primary or secondary medical display, but also performs acceptance and constancy tests to verify that displays consistently conform to such international regulations as: NEMA DICOM part 14, GSDF, AAPM TG-18, DIN 6868-57, DIN 6868-157, JESRA X-0093, IEC 62563-1 ACR and NYS/NYC Primary Diagnostic Monitor guidelines (NY PDM).
The PerfectLum Suite is the preferred medical display calibration and quality control solution used by hospitals, teleradiology companies, university health departments, and other medical facilities, worldwide. The integration of PerfectLum with the Apple 5K iMac 27”, creates a perfect pairing. Read more about PerfectLum
Marc Leppla, CTO at QUBYX, said:
“QUBYX shows again its capacity to significantly enhance display performance in any environment, including medical monitors, laptops, and commercial displays, while also reducing costs for medical institutions.”
About QUBYX
QUBYX is a software/hardware manufacturer providing new dimensions of image quality in the medical imaging industry and display calibration field.
For more information, visit: https://qubyx.com
Press Contact:
Marc Leppa CTO
QUBYX Medical Solutions Inc.