FDA Clearance for Mobile Usage of Novel iOS Application in End-to-End Enterprise Imaging Platform

The first native iPhone Operating System (iOS) application (app) to be used as a core component of an enterprise imaging platform has received US Food and Drug Administration (FDA; Silver Spring, MD USA) 510(k) clearance for mobile diagnostic interpretation.

The app was approved for mobile use in all imaging modalities except mammography, and is a thin-client app optimized for simple, fast access to images and reports. The use of server-side processing enables the app to display large multi-gigabyte studies, even over cellular networks, without performance degradation.


The Visage Ease Pro app was developed by Visage Imaging (Richmond, VIC, Australia), a subsidiary of Pro Medicus (Richmond, VIC, Australia). Visage Ease Pro is a core component of the Visage 7 Enterprise Imaging Platform.

Visage Ease Pro uses secure multi-factor authentication, displays non-DICOM/non-diagnostic images, can be used to upload photo attachments to studies on the Visage 7 platform, allows iOS Push Notifications and app-to-app integration using the Visage 7 protocol handler, and supports recording of voice memos.

Visage Ease Pro can be downloaded for free from the Apple App Store, and works with Visage version 7.1.6 or higher. Visage Ease Pro also has the CE Marking for mobile diagnostic.

Malte Westerhoff, chief technology officer at Visage Imaging, said, “The platform responsible for the power of Visage Ease Pro is Visage 7, with its smart server-side processing capabilities. No separate servers dedicated for mobile use are required as it’s all integrated into one universal viewing platform. Tens of millions of annual studies can be processed by a single Visage 7 system for high-volume diagnostic interpretation by hundreds of radiologists, clinical review by tens of thousands of clinicians, and now with Visage Ease Pro, near anywhere mobile diagnostic interpretation.”

Related Links:
Visage Imaging
Pro Medicus