Agfa HealthCare Receives FDA 510(k) Clearance for Advanced Clinical Applications on XERO Universal Viewer

MORTSEL, Belgium and GREENVILLE, South Carolina, July 27, 2017 /PRNewswire/ --

• The XERO Viewer is part of Agfa HealthCare's award-winning Enterprise Imaging platform, which consolidates imaging data from multiple service lines and provides secure access to a patient's medical images, in one view, accessible 'anywhere, anytime'.
• KLAS honored the XERO Viewer with its 2017 Category Leader Award, noting Agfa HealthCare's continuous improvement of the solution.
• Full Fidelity Mobile (mobile diagnostic review and analysis on an iPad) now includes ECG images and reports.

Agfa HealthCare announces today that it has received FDA 510(k) clearance for the XERO Xtend functionalities of the Enterprise Imaging zero-footprint viewer. XERO Xtend adds 3D processing and advanced clinical applications to the XERO Viewer. It is now FDA-cleared for diagnostic viewing on desktop devices.¹ The release data for 510K cleared XERO Xtend will be communicated by Agfa HealthCare's regional sales teams.

Versatile, powerful universal viewer
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.

Images from the Agfa HealthCare Enterprise Imaging IT platform or third-party VNAs or PACS can be seen securely in one display. XERO Viewer connects more service lines than any other product in the market.

Powerful tools, more modalities
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 (center line, Cobb Angle, Hip-Knee-Ankle Angle, etc.); mammography tools (including displays and tools for optimal viewing); and nuclear medicine tools (color highlighting palettes stored as window level presets).

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.

Winning product quality, range of attributes
The XERO Viewer recently received top honors from KLAS, with its 2017 Category Leader Award. This is the first year the healthcare quality research organization has included a Universal Image Viewer category. The Category Leader designation is reserved for vendor solutions that lead select market segments in which at least two products meet a minimum level of KLAS confidence. According to the latest KLAS Performance Report, Agfa HealthCare is one of two vendors offering universal viewers that are fast and reliable, and noted for continually improving their solutions.

"We focus our continuous improvement efforts on meeting specific and real needs of healthcare providers; the features included in XERO Xtend fit that criterion," comments James Jay, President, 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."

For an image, courtesy of Agfa HealthCare, click here

About Agfa HealthCare
Agfa HealthCare, present in one hospital out of two, is a leading provider of eHealth & Digital Imaging solutions. Care organizations in over 100 countries rely on Agfa HealthCare to optimize their efficiency and improve patient care.

¹ This FDA 510k clearance for Xtend functionality does not include mobile viewing using the XERO Viewer at this time.

Miriam Ladin
Director, Marketing Communications, Americas
T +1-401-604-2203
miriam[email protected] 

SOURCE Agfa HealthCare