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The EMS9UA Transcranial Doppler Ultrasound System is intended for use as a diagnostic ultrasound fluid flow analysis system: 1) For the measurement of cerebral artery blood velocities to determine the presence of hemodynamically significant deviations from normal values 2) To assess arterial cerebral blood flow for the occurrence of micro embolic signals. Vessels intended for observation include, but are not limited to the middle, anterior and posterior cerebral arteries, via the temporal windows, the vertebral mid basilar arteries via the foramen magnum and the ophthalmic artery and intracranial internal carotid artery via the eye. The Roboprobe Headband facilitates monitoring use by its ability to track the Doppler signal. The EMS9UA Transcranial Doppler is intended for use during: a) Diagnostic exams b) Surgical interventions The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.

Shenzhen Delicate believes that the Model EMS-9UA is substantially equivalent to its EMS OU Transcranial Doppler which was cleared on May 5, 2006 510kH K060112. The EMS-9UA has the same device description except that the head frame used for longer term monitoring has the ability to track the Doppler signal and therefore not lose the signal with patient movement and time. The tracking is accomplished by adding to the EMS9U an additional circuit which detects the ultrasound Doppler return and positions the face of the probe in the headband to maximize the detected ultrasound return. The headband electronics does not change or interfere with the transmitted ultrasound. Except for the servo motor controller added to the circuitry of the EMS9U range and the software added to control it, and the modifications to the INNSO Tange and the servo motor controlled probe, the EMS9U range and the EMS- 9UA are identical internally and functionally. The probes are identical to those cleared in K060112.