Carestream Health has received the US Food and Drug Administration (FDA) approval letter for its high-resolution computed radiography (CR) system for mammography, to begin commercial distribution of CR system in US.
The company’s Carestream Directview CR mammography feature enables mammography images to be captured digitally while utilising a healthcare provider’s existing mammography x-ray unit and workflow processes and is intended for use in the same clinical applications as traditional screen-film based mammography systems.
Carestream Health Women’s Healthcare general manager Dina Vazzana said that annual mammograms for women are important for good health and CR mammography system will provide healthcare organizations with yet another option for providing high-quality screening for breast cancer.
“This high-performance, cost-effective system will enable medical facilities to benefit from advanced digital medical imaging technology in a way that complements their patient-focused operations,” Vazzana said.
Carestream Health said that its CR systems can be used for both general radiography and mammography exams and in addition, the optional Carestream Directview CR Mammography Total Quality Tool is available to streamline objective mammography image testing and QC measurements.