November 23, 2022 — KA Imaging’s innovative Reveal 35C flat panel detector has received the EU MDR CE Mark certificate from the EU Notified Body. The X-ray detector, powered by patented SpectralDR technology, is now qualified for sale in any of the 27 countries of the European Union, as well as the four countries that are part of the European Free Trade Association ( EFTA).
“This is a very exciting time for us at KA Imaging,” said Amol Karnick, President and CEO of KA Imaging. “We are engaged in conversations with many clinical sites in Europe, and the CE mark will allow us to do installations and begin imaging patients,” Karnick said.
KA Imaging’s SpectralDR technology enables dual-energy subtraction, providing bone and tissue differentiation with a single standard X-ray exposure. It acquires three images simultaneously (DR, dual-energy X-ray images of bone and soft tissue). The technology mimics the workflow, dose, and techniques of state-of-the-art DR mobile X-ray detectors.
“With SpectralDR, the Reveal 35C takes general radiography to the next level, as you can simultaneously obtain true bone and soft tissue subtracted images for any clinical radiology task, as well as a high-quality DR image in one exposure at the lowest dose,” said Dr. Karim S. Karim, CTO at KA Imaging.
Spectral images provide better visualization of abnormalities, including indeterminate lung nodules, coronary calcium, pneumonia, line and tube ends, pneumothorax, indwelling devices, and retained surgical bodies.
For more information: www.kaimaging.com