Visage Imaging Mobile Diagnostics App Approved by FDA

The FDA has adopted the 510(k) application for the iOS application of Visage Ease Pro from Visage Imaging. (Note: Before the product goes on the market, it submits a certificate to the FDA indicating the safety and effectiveness of the sale in the market. The application is 510(k), which is equivalent to the qualification for legal sale), except for mammograms. The mobile diagnostics app translates most of the image information.

Visage Ease Pro is part of the Visage 7 imaging platform, which uses a thin client (combined with a high-performance CPU, a stand-alone embedded operating system that can replace a PC's flexible and compact computer products) and server-side technology, and is perfectly processed using cellular neural network algorithms. Massive research information. At the same time, the app can also display medical digital images and communication information, record voices or upload scientific research related photos.

Visage Imaging also complies with FDA's mobile app law, which means that mobile devices can only be enabled for diagnostics in the absence of a full diagnostic workstation, and mobile devices are prohibited from processing mammogram information. The company stated that Visage Ease Pro can only be integrated into iPads. The smaller screen iPhone is not suitable, and user reminders can be displayed on the iPhone app.

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