Model note · Transcranial Doppler
Natus Sonara transcranial Doppler system
The Sonara is a transcranial and peripheral vascular Doppler system that measures blood flow velocities in intracranial, extracranial and peripheral vessels without needles or contrast. It is used in neurology, stroke units, neurocritical care and vascular labs, including long term monitoring with a headset mounted probe. It comes either as an all in one cart with an integrated touchscreen PC or as Sonara/tek, the same hardware run from a separate computer over USB.
The model
Maker, model and type.
- Maker
- Natus Medical Incorporated (originally Viasys Healthcare NeuroCare)
- Model
- Sonara transcranial Doppler system (unilateral and bilateral; Sonara/tek PC version)
- Device type
- Transcranial Doppler
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Display and computer (Sonara) | Integrated 15 inch colour touchscreen LCD with built in PC board and hard disk | Source |
| Sonara/tek variant | Same device operated from a personal computer through a USB connection | Source |
| Probe frequencies | 2 MHz, 4 MHz and 8 MHz, unilateral or bilateral | Source |
| Monitoring probe | Dedicated 2 MHz monitoring probe that fits a headset | Source |
| Displays | Spectral Doppler plus M-mode; output power shown at all times while scanning | Source |
| Accessories | Remote control and footswitch; online and offline operating modes | Source |
| Standards | IEC/EN 60601-1, 60601-1-2 and 60601-2-37 | Source |
| FDA clearance | 510(k) K060421, decision 3 November 2006, class II, product codes IYN and ITX | Source |
Recalls
Known FDA recalls.
- Z-0998-20092009-01-06
Sonara unilateral: lock ups, shutdowns or system errors, and possible cooling fan wiring fault.
FDA record - Z-0999-20092009-01-06
Sonara bilateral: same lock up, shutdown and fan wiring issues.
FDA record
Safety
Safety warnings from the record.
- A staff member reported a shock when touching a 2 MHz probe to the neck; the unit and probe were returned for engineering inspection. Treat any such report as a removal from use event. Source
- Acoustic output is kept below pre-amendment intensity levels and the power level is shown during scanning, so operators should keep exposure as low as practical. Source
Sources
Where this note comes from.
- FDA 510(k) summary K060421, Sonara and Sonara/tek
- FDA recall Z-0999-2009 record
- openFDA recall records, Sonara
- openFDA MAUDE reports, Sonara
Not covered: The Natus product page blocked access and the Sonara user manual (Rev 09, 2016) is only available behind a terms agreement on a third party library, so no current specifications, troubleshooting steps or error messages could be checked; MAUDE holds only three reports.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Transcranial Doppler
Other models of this device.
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