Pioneer TC8080 Companion III
510(k) K053648
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053648 | Date24 Jan 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 19 Sep 2026
The Pioneer TC8080 Companion III is a portable transcranial Doppler ultrasound system designed to measure blood flow velocity within cerebral vessels. It employs Doppler ultrasound technology to provide real-time assessment of intracranial hemodynamics, aiding in the evaluation of conditions such as stroke, cerebral vasospasm, and other neurovascular disorders.
This device is intended for use in clinical settings such as hospitals and neurocritical care units. Supplied as a reusable system, it requires proper maintenance and calibration to ensure accurate performance. The Pioneer TC8080 Companion III holds FDA 510(k) clearance under the classification of an abbreviated submission (K053648), adhering to regulatory standards for diagnostic ultrasound devices.
Other devices from Viasys Neuro Care
Questions
AI-generated answers, 19 Sep 2026
What clinical conditions is the Pioneer TC8080 Companion III primarily used to evaluate in neurocritical care settings?
The Pioneer TC8080 Companion III is designed to measure blood flow velocity in cerebral vessels using Doppler ultrasound technology. It aids in assessing conditions like stroke, cerebral vasospasm, and other neurovascular disorders by providing real-time intracranial hemodynamics data, which helps clinicians monitor blood flow dynamics in critical care scenarios.
Is the Pioneer TC8080 Companion III a single-use or reusable device, and what maintenance is required?
The Pioneer TC8080 Companion III is supplied as a reusable system, meaning it is intended for repeated use in clinical settings. To ensure accurate performance, it requires proper maintenance and calibration, as outlined in the manufacturer’s instructions, to sustain reliable diagnostic functionality over time.
How was the regulatory pathway for the Pioneer TC8080 Companion III determined, and which advisory committee was involved?
The Pioneer TC8080 Companion III was cleared through an abbreviated 510(k) submission (K053648) under the classification of diagnostic ultrasound devices. The device was reviewed by the Radiology (RA) Advisory Committee, which advised on its substantial equivalence to existing products in the same category (product code IYN).
What type of facility is the Pioneer TC8080 Companion III intended for, and why?
The Pioneer TC8080 Companion III is intended for use in clinical settings such as hospitals and neurocritical care units. Its portable design and specialized Doppler ultrasound capabilities make it ideal for monitoring cerebral blood flow in high-acuity environments where real-time assessment of neurovascular conditions is critical.