Interspec 2 MHz Transcranial Pulsed Wave Doppler

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K900155 ↗

FDA Product Code

ITX

Device Class

Class II

Regulation

21 CFR Part 892.1570

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Cardioscan with Doppler Option

  Class II

  FDA 510(k) K862913 Active Cleared 4 Nov 1986

• Interspec Apogee Echocardiograph

  Class II

  FDA 510(k) K903839 Active Cleared 16 Nov 1990

• Ultrasound Imagaing System and Doppler Flowmeter

  Class II

  FDA 510(k) K920678 Active Cleared 2 Apr 1992

• Ultrasonic Imaging System (Modified)

  Class II

  FDA 510(k) K860568 Active Cleared 11 Aug 1986

• Cardioscan Doppler Option

  Class II

  FDA 510(k) K860579 Active Cleared 30 Jun 1986

• Interspec Apogee, Modification

  Class II

  FDA 510(k) K910049 Active Cleared 29 Apr 1991

See all devices from Interspec, Inc. →

• What is the Interspec 2 MHz Transcranial Pulsed Wave Doppler used for?

  This device is designed for transcranial Doppler (TCD) imaging, emitting low-frequency pulsed waves to assess blood flow velocity within cerebral arteries. Clinicians use it to evaluate cerebrovascular conditions such as stenosis, aneurysms, or emboli by analyzing real-time Doppler shifts through the skull. The non-invasive approach helps monitor hemodynamic parameters without surgical intervention.

• How is the Interspec 2 MHz Transcranial Pulsed Wave Doppler supplied and maintained?

  The device is supplied as a reusable medical instrument, intended for use in radiology settings. Proper calibration and regular maintenance are essential to ensure accurate and reliable performance. Since it is reusable, adherence to manufacturer guidelines for cleaning, disinfection, and inspection is critical to prevent cross-contamination and maintain diagnostic precision.

• Is sterility or MRI safety information provided for this device?

  The available data does not specify sterility requirements or MRI safety information for the Interspec 2 MHz Transcranial Pulsed Wave Doppler. Standard precautions for ultrasound transducers, such as cleaning and disinfection between uses, should be followed. If MRI compatibility is needed, additional manufacturer documentation or testing may be required.

• What regulatory pathway was followed for FDA clearance of this device?

  The Interspec 2 MHz Transcranial Pulsed Wave Doppler received FDA 510(k) clearance under the traditional review pathway. It was classified as substantially equivalent (SESE) to a predicate device, meaning the FDA determined it had the same intended use, technological characteristics, and performance as a legally marketed device already on the market.

• What are the key specifications or limitations to consider when using this device?

  This device operates at a frequency of 2 MHz and is classified under product code ITX (Transducer, Ultrasonic, Diagnostic). It is intended for transcranial use, meaning it relies on acoustic windows in the skull to assess cerebral blood flow. The device’s performance depends on proper transducer placement and patient-specific factors, such as skull thickness or acoustic window availability.