Explorer CVS Transcranial Doppler
by Diagnostic Medical Systems 510(k)
Active
510(k) K990517
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990517 | Date1 Aug 2000 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Explorer CVS Transcranial Doppler is a pulsed Doppler ultrasound imaging system (Device Type: IYN) designed for non-invasive assessment of blood flow within cranial and peripheral vasculature. It employs multiple frequency transducers (2 MHz, 4 MHz, and 8 MHz) to capture ultrasound signals, enabling real-time evaluation of vascular conditions such as stenosis, aneurysms, or cerebral perfusion disorders. As a diagnostic tool, it aids clinicians in monitoring hemodynamic parameters critical to neurological and cardiovascular health.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as hospitals, neurology clinics, or diagnostic imaging centers. It requires sterile probe covers for patient contact and is classified under FDA 510(k) clearance (K990517) with a Traditional review pathway under the Radiology Advisory Committee. Compliance with Class II special controls for pulsed Doppler ultrasound systems ensures adherence to regulatory standards for safety and performance. Storage and maintenance follow manufacturer guidelines to preserve transducer integrity and imaging accuracy.
Other devices from Diagnostic Medical Systems
Questions
AI-generated answers, 1 Oct 2026
What is the Explorer CVS Transcranial Doppler used for?
The Explorer CVS Transcranial Doppler is designed for non-invasive evaluation of blood flow within cranial and peripheral blood vessels. Clinicians use it to assess conditions such as stenosis, aneurysms, or cerebral perfusion disorders by analyzing ultrasound signals in real time. This helps monitor critical hemodynamic parameters essential for neurological and cardiovascular health.
How is the Explorer CVS Transcranial Doppler supplied and prepared for use?
This device is supplied as a reusable medical instrument intended for clinical environments like hospitals or neurology clinics. Before patient use, sterile probe covers must be applied to the transducers to ensure hygiene and safety. The system requires adherence to manufacturer guidelines for storage and maintenance to preserve transducer integrity and imaging accuracy.
What frequency transducers does the Explorer CVS Transcranial Doppler include?
The Explorer CVS Transcranial Doppler features multiple frequency transducers—specifically 2 MHz, 4 MHz, and 8 MHz—to capture detailed ultrasound signals. These varying frequencies allow for optimized imaging and assessment of blood flow in different vascular contexts, enhancing diagnostic precision.
Is the Explorer CVS Transcranial Doppler single-use or reusable?
The Explorer CVS Transcranial Doppler is a reusable medical device. However, sterile probe covers must be used for each patient interaction to maintain sterility and compliance with clinical protocols. Proper cleaning, storage, and maintenance are required between uses to ensure device performance and longevity.
What regulatory pathway does the Explorer CVS Transcranial Doppler follow?
The Explorer CVS Transcranial Doppler has received FDA 510(k) clearance under the product code IYN (Pulsed Doppler Ultrasound Systems) with a Traditional review pathway. It was reviewed by the Radiology Advisory Committee and complies with Class II special controls for pulsed Doppler ultrasound systems, ensuring regulatory standards for safety and performance are met.