Transcran Transcranial Pulsed Doppler System

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

Full name

Transcran(Tm) Transcranial Pulsed Doppler System

510(k) Number

K882015 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Ultramed Tf 122 Ultrason Vascu Imag & Doppler Syst

  Class II

  FDA 510(k) K861378 Active Cleared 7 Jul 1986

• Phacoemulsification Ultrasonic Fragment System

  Class II

  FDA 510(k) K862021 Active Cleared 23 Jun 1986

• Phacoemulsification Tip

  Class II

  FDA 510(k) K850578 Active Cleared 3 Apr 1985

• Dopplex Ultrasonic Doppler System

  Class II

  FDA 510(k) K873989 Active Cleared 2 Mar 1988

• What is the Transcran Transcranial Pulsed Doppler System used for?

  This device is designed for transcranial Doppler imaging, which evaluates blood flow velocities within intracranial vessels in real-time. It helps diagnose and monitor conditions like stroke, vasospasm, or intracranial hemorrhage by assessing cerebral hemodynamics using pulsed Doppler principles. The non-invasive technique relies on transcranial windows to detect flow characteristics, making it useful for clinical evaluations where cerebral circulation is a concern.

• How is the Transcran Transcranial Pulsed Doppler System supplied and intended for use?

  The system is supplied as a standalone ultrasound device and is intended for use in radiology settings. While typical transcranial Doppler systems are reusable with proper cleaning and maintenance, the regulatory data for this specific model does not explicitly state whether it is single-use or reusable. Users should follow standard decontamination protocols if reuse is intended, though no specific sterility or cleaning instructions are provided in the available documentation.

• Is the Transcran Transcranial Pulsed Doppler System sterile?

  The regulatory data for this device does not specify any sterility requirements or indicate whether the system is pre-sterilized. If reuse is planned, it would require appropriate cleaning and sterilization procedures to ensure patient safety. Always follow manufacturer guidelines or clinical best practices for device reprocessing.

• What storage and handling instructions apply to the Transcran Transcranial Pulsed Doppler System?

  The available data does not provide detailed storage or handling instructions for this device. Proper storage typically involves keeping the system in a clean, dry environment, protected from physical damage, and following any manufacturer-recommended conditions to maintain functionality. If the device is reusable, ensure it is stored in a way that prevents contamination before use.

• What regulatory pathway was followed for the Transcran Transcranial Pulsed Doppler System?

  The device was cleared under the FDA 510(k) pathway with the clearance number K882015, filed in 1988. It was classified under product code IYN (Ultrasound Imaging Systems, Diagnostic, Pulsed Doppler) and reviewed by the Radiology Advisory Committee. The decision was based on substantial equivalence to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously cleared product.