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The RealView Telemedicine System is used for medical digital image capture, storage, retrieval, and transmission over telecommunications media. A physician would use our system to take images of a patient for a permanent record of their condition and also to send them to a colleague for referral purposes or a consultation. The condition.

The system consists of hardware that attaches to a physician's examining equipment, video camera, Personal Computer (PC) containing a video capture card, sound card and modem, and running Windows 95® operating system and RealView™ Telemedicine Software and foot pedals for image capture.

This document is a 510(k) clearance letter from the FDA for a device called the "RealView Telemedicine System." It announces that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the acceptance criteria, reported device performance, or details about the study that proves the device meets acceptance criteria. It is a regulatory approval letter, not a performance study report.

Therefore, I cannot provide the requested information based solely on the provided text. The letter only confirms that the device can be marketed.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data and acceptance criteria.

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