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The Sonara and Sonara/tek Transcranial Doppler are medical ultrasound devices for measuring the blood flow velocities in arteries and in veins noninvasively, consistent with the FDA Ultrasound System and Transducer Indication for Use forms cleared with the 510(k).

The Sonara device is a Transcranial and peripheral vascular Doppler system, which is designed to measure blood flow velocities and other hemodynamic parameters in a non-invasive manner, in intracranial, extracranial and peripheral blood vessels. The Sonara system includes an integrated 15" touch screen color LCD display, integrated PC board and hard disk for data management and display. The Sonara/tek is the same device, utilizing a personal computer for its opcration (via USB connection). The TCD system supports 2MHz, 4MHz and 8MHz ultrasound probe frequencies, either in a unilateral or bilateral configuration. For monitoring purpose, a special 2MHz monitoring probe (which fits into a headset) is provided. Online and Offline modes of operation are available. The system also includes a remote control and footswitch as accessories.

The Comfort Cup and Ear Tip accessories are for use with non-Grason Stadler (GSI) Audiometer, Otoacoustic Emission and Auditory Brainstem Response devices and are patient applied parts to support auditory evaluation studies.

The audiometer, otoacoustic emission (OAE) and auditory brainstem response (ABR) accessories addressed in this pre-market notification are Comfort Cup and Eartip. These devices are used to couple auditory stimulus into the ear or ear canal to support audiometer, OAE and ABR testing. Both devices connect to the audiometer, OAE and ABR devices through a sound conducting tube. The sound from the audiometer, OAE and ABR devices are conducted through the sound conducting tube to the ear in the application of the Comfort Cup or to the ear canal in the applications of the Eartip. The Comfort Cup and Eartip accessories are single patient use disposables.