Press Release: April 17, 2020
QUBYX receives FDA clearance for OptikView Display in bundle with PerfectLum DICOM calibration software
Wilmington, DE., April, 15,2020 - QUBYX is excited to announce, that it again received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a display bundle with QUBYX PerfectLum DICOM calibration software.
“We are extremely happy with FDA's decision to approve the OptikView & PerfectLum Bundle.” - says Marc Leppla, Director and CTO of QUBYX. “Our long-term development has become very rewarding this year.”
Optikview Gup2103cmi overview
The OptikView Gup2103cmi is a 21” 3MP monitor which is designed specifically for the demanding medical imaging environment. The FDA 510(k) number is K191705
Previously PerfectLum did receive FDA clearance with the following displays:
Dell Ultrasharp U3011 W/Qubyx Perfectlum Bundle K111385
Dell U3014 With Qubyx Perfectlum Bundle K131601
Diva Zsp5812cmi With Qubyx Perfectlum Bundle K152847
Dell Up3216q With Qubyx Perfectlum Bundle K162196
Dell Up3017 With Qubyx Perfectlum Bundle K171229
Diva Zsp2105cmi With Qubyx Perfectlum Bundle K160328
PerfectLum software overview
QUBYX PerfectLum is a calibration and quality control application that significantly enhances the performance of any display in accordance with medical imaging requirements, including NEMA DICOM part 14 GSDF. The software also performs acceptance and constancy tests to verify that the display conforms to such regulations as AAPM TG18, new DIN 6868-157, JESRA X-0093, IEC 62563-1, ACR, NY State PDM and NY City PDM Guidelines.
According to the recently issued FDA 510(k) clearance, the bundle of Optikview Gup2103cmi monitor & QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
QUBYX, a software manufacturer providing the new dimension of image quality in the medical imaging industry and display calibration field since 2002. For more information about the company visit www.qubyx.co