Agfa Gets FDA Nod for Mobile Diagnostic Viewer

Agfa HealthCare propels enterprise imaging strategy with FDA clearance for XERO Viewer.

Agfa HealthCare announced yesterday they received FDA 510(k) clearance for diagnostic viewing with the XERO Viewer.

The XERO Viewer offers full fidelity view functionality using lossless compression to provide diagnostic quality when images are displayed, by retrieving original-quality renditions of stored DX, CT, MRI, CR, and US images, Agfa said in a release.

The XERO Viewer makes images accessible on a single browser-based viewer, giving it the ability to image enable the EMR and provide secure access to DICOM and non-DICOM imaging data from different departments and multiple sources in and out of the hospital, Agfa said.

The interface provides search, filter, and discovery functions and allows clinicians and radiologists to make annotations and markups, adapt brightness and contrast, or pinpoint an area of interest and compare it across different studies, the release said. Users can view ECGs in various layouts, change waveform size and amplitude, and compare image data with previous ECGs.

The viewer boasts mobile device support and chat and share tools to allow colleagues to look at the same image and make markups in real-time viewing/communication.

"The XERO Viewer demystifies imaging and makes it accessible to everyone in the patient's care continuum," James Jay, vice president Imaging IT solution of Agfa HealthCare, said in the release.

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