Dolphin/IQ and Dolphin/4D
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Viasonix Ltd
Identifiers
- 510(k) Number
- K170859 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Dolphin/IQ and Dolphin/4D are transcranial Doppler (TCD) devices designed for non-invasive measurement of cerebral blood flow velocities. These systems utilize ultrasound technology to assess blood flow within the intracranial vessels, aiding in the evaluation of cerebrovascular conditions such as stenosis, vasospasm, or perfusion abnormalities. Both modules are categorized as diagnostic ultrasound devices, specifically for TCD applications, and are intended for clinical use in radiology settings.
The Dolphin/IQ operates as a compact, external module interfacing with an external PC to deliver TCD functionality, offering a cost-effective alternative to standalone systems. The Dolphin/4D is an all-in-one, standalone TCD machine with integrated software and hardware for independent use. Both devices are classified under the product code IYN and are supplied as reusable medical equipment, adhering to FDA 510(k) clearance and EU MDR regulatory standards. They are intended for use in clinical environments where cerebral hemodynamics assessment is required.
Frequently asked questions
What is the primary clinical use for the Dolphin/IQ and Dolphin/4D devices, and how do they differ in their setup requirements?
The Dolphin/IQ and Dolphin/4D are transcranial Doppler (TCD) devices used to measure cerebral blood flow velocities non-invasively, helping assess conditions like stenosis, vasospasm, or perfusion issues. The Dolphin/IQ is a compact external module that requires pairing with an external PC for operation, making it a budget-friendly option for clinics without standalone systems. In contrast, the Dolphin/4D is an all-in-one, standalone machine with integrated software and hardware, allowing independent use without additional equipment.
Are the Dolphin/IQ and Dolphin/4D devices single-use or reusable, and what does this mean for maintenance and cleaning?
Both the Dolphin/IQ and Dolphin/4D are designed as reusable medical devices. This means they are built for repeated use in clinical settings, requiring proper cleaning, disinfection, and maintenance protocols to ensure reliability and patient safety. Reusability also implies that facilities must follow manufacturer guidelines for servicing and calibration to maintain performance over time.
How do I determine which model, Dolphin/IQ or Dolphin/4D, is best suited for my radiology department’s workflow?
Choose the Dolphin/IQ if your department already has compatible PCs and needs a cost-effective TCD solution that interfaces externally. Opt for the Dolphin/4D if you require a fully independent, standalone system with no additional hardware dependencies, ideal for standalone radiology suites or smaller clinics where portability and self-contained operation are priorities.
What regulatory pathways have the Dolphin/IQ and Dolphin/4D followed, and how does this impact their use in clinical settings?
Both devices have undergone FDA 510(k) clearance and comply with EU MDR standards, confirming they meet regulatory requirements for diagnostic ultrasound devices under product code IYN. This means they are authorized for clinical use in the U.S. and EU, adhering to safety and performance standards set by these regulatory bodies. The clearance also indicates they are considered substantially equivalent to predicate devices, ensuring their design and functionality align with established medical device standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dolphin/IQ - High End TCD Module by Viasonix, Dolphin/4D - Superior TCD Device by Viasonix, Viasonix Dolphin/IQ Transcranial Doppler · ICare Life Medical Devices, Inc., K191023 - Dolphin/IQ | FDA 510 (k) | Viasonix , Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170859 | Class II | Active |
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Manufacturer
- Manufacturer
- Viasonix Ltd
- FDA Applicant
- Viasonix , Ltd.
Sources (2)
- FDA 510(k) K170859 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026