Technology | Remote Viewing Systems | November 07, 2016

Remote image viewing application receives FDA 510(k) clearance

November 7, 2016 — Utah-based healthcare technology company Novarad has recently received U.S. Food and Drug Administration (FDA) 510(K) clearance of its MobileRad native iPad application, which is now available on the App Store.

The Novarad MobileRad application integrates with a facility’s NovaPACS (picture archiving and communication system) to display data on a third-party mobile device for diagnostic use, specifically the native app (MobileRad) on iPad. NovaPACS is approved for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc.

The app allows healthcare providers to view images and reports anytime, anywhere.

Clinical testing was conducted independently by a panel of board-certified radiologists in the United States. Each radiologist agreed that images on the native app were comparable to those on the predicate NovaPACS workstation across seven modalities, and of adequate quality for clinical and diagnostic use.

Each radiologist agreed they made the same diagnosis on their iPad as they would have made on the workstation.

Mobile devices are not intended to replace a full workstation and should be used only when there is no access to a workstation and with respect to proper lighting conditions. They are also not to be used for mammography.

For more information: www.novarad.net

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