Model note · Transcranial Doppler

DWL Doppler-BoxX transcranial Doppler unit

Name: DWL Doppler-BoxX transcranial Doppler unit
Brand: DWL Doppler-BoxX

The Doppler-BoxX is Compumedics DWL's compact transcranial Doppler unit that plugs into an external Windows PC instead of carrying its own screen. It runs pulsed wave TCD with Doppler M-mode at 1, 2 and 2+2.5 MHz, CW and PW at 4 and 8 MHz, and a 16 MHz intraoperative microprobe, and supports routine exams, monitoring, emboli detection and CO2/VMR testing through software modules. It descends from the original Doppler-Box cleared by FDA in 2005.

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The model

Maker, model and type.

Maker: Compumedics Germany GmbH (DWL)
Model: Doppler-BoxX transcranial Doppler unit (PC connected)
Device type: Transcranial Doppler
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Size and weight	10 x 18.5 x 28 cm; 2.6 kg	Source
Doppler frequencies	PW 1, 2, 2+2.5 and 16 MHz; PW and CW 4 and 8 MHz (some not available in the USA)	Source
Channels and spectra	1 to 2 Doppler channels; 1 to 9 spectrum windows	Source
Depth gates	Up to 400 gates and 8000 microgates	Source
Maximum measurable velocity	Up to 1900 cm/s on the data sheet (product page states 1,200 cm/s)	Source
Interfaces	8 analogue inputs, 4 analogue outputs, Ethernet 10/100/1000; DICOM, HL7, GDT optional	Source
Monitor data links	Philips IntelliBridge and ICM+ (monitoring software only)	Source
Minimum PC operating system	Windows 10 Pro	Source
Regulatory	MDD Class IIa for system and probes; FDA K051085	Source

Recalls

Recalls.

This note lists no recalls. Check the FDA recall database for the latest record.

Safety

Safety warnings from the record.

Only disinfectants tested for material compatibility should be used; untested agents may damage probes or housing. Source
The 16 MHz probe is used intraoperatively and needs validated reprocessing between patients. Source

Sources

Where this note comes from.

Not covered: No operating or service manual was opened, so error messages, acoustic output calibration and maintenance intervals are missing. The 510(k) summary text is partly unreadable in the scanned PDF and covers the older Doppler-Box. The data sheet and product page disagree on maximum velocity (1900 vs 1,200 cm/s). No FDA recall or MAUDE records were found for this brand.

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