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The indications for use of the VIEWSEND Medical System, as described in its labeling, are the same as the previously cleared devices marketed and distributed by KLT telecom, Inc. (K-962225). The VIEWSEND Medical System has the same intended use as the originally cleared device. When installed on an appropriate PC-based platform, the VIEWSEND Medical System is intended to provide the medical professional with the capability to comnare, manipulate, annotate, collaborate, and/or transmit medical images in order to render a diagnosis. Digital image storage in system RAM and hard drive standard is with lossless compression or without data compression. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/or security. Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA

The VIEWSEND Medical System is a modular software program providing telemedicine, teleradiology, and videoconferencing capabilities. The system may also utilize some or all of the following components: (1) DICOM, (2) Zydacron, (3) Canon Communication Camera, (4) COHERENT Call Port Display Audio Conferencing System, (5) Canon RE-650 MKH Video Visualizer Document Camera.