Second Opinion®- User Manual

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Adverse Effects

There are no known direct risks related to the use of the device to the safety or health of the user or the patient. Patients have no direct contact with the device. Indirect inherent risks are: (a) the device may not detect pathologic or non-pathologic features that present in radiographs(false negative detections); and (b) that the device may detect pathologic or non-pathologic features that do in fact present in radiographs (false positive readings). These possibilities are clearly explained in the warnings section included in the labeling of the device.Proper operation of the device is explained in the directions for use printed in this manual.The Second Opinion® output is one of several inputs that physicians employ in their decision making; final diagnostic decisions represent physicians’ assessments and judgments derived from these several inputs.