Belgium-based Agfa HealthCare has received FDA 510(k) clearance for the XERO Xtend functionalities, including 3D processing and advanced clinical applications, in the company’s enterprise imaging XERO Viewer.
“We focus our continuous improvement efforts on meeting specific and real needs of healthcare providers; the features included in XERO Xtend fit that criterion,” says James Jay, president of imaging IT solutions at Agfa HealthCare. “XERO, and the XERO Xtend feature set, help the healthcare enterprises to provide anywhere, anytime image access complete with powerful, useful image processing functions. The FDA 510(k) clearance for XERO Xtend supports our continued march forward.”
The XERO Viewer provides secure access to DICOM and non-DICOM imaging data from different departments and multiple sources, in one view, to anyone inside and outside of the hospital who is subject to defined security policies and access rights.
XERO Xtend is an optional feature set for the XERO Viewer. It includes MIP (maximum intensity projection), MPR (multiplanar reconstruction) and 3D visualization tools; orthopaedic tools; mammography tools; and nuclear medicine tools.
Agfa HealthCare has also expanded the types of modalities that can be used for diagnostic review and reporting in XERO. Uncompressed or non-lossy compressed images intended “for presentation” may be used for diagnosis or screening when viewed on monitors that have been cleared by the FDA.
In addition, the Full Fidelity Mobile functionality (mobile diagnostic review and analysis on an iPad), which received FDA 510(k) clearance in 2015, now includes ECG images and reports.
