Dolphin/IQ, Dolphin/4D, Dolphin/MAX with Dolphin/XF Robot Accessory
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Viasonix Ltd
Identity
- Trade Name
- Dolphin/MAX EUDAMEDDolphin/IQ EUDAMEDDolphin FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Dolphin/IQ EUDAMEDThe Dolphin/IQ is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin/IQ system can be used in hospitals, clinics and physician offices FDA UDIThe Dolphin/MAX is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin/MAX system can be used in hospitals, clinics and physician offices FDA UDI
- Model / Reference
- Dolphin product family – Transcranial Doppler systems EUDAMEDPVC0227 EUDAMEDPVC0200 EUDAMEDIQ FDA UDIMAX FDA UDI
- Description
- The Dolphin/IQ is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin/IQ system can be used in hospitals, clinics and physician offices FDA UDIThe Dolphin/MAX is a medical Doppler device intended for noninvasive measurements of blood flow velocities in arteries and veins in adults and Pediatric. The Dolphin/MAX system can be used in hospitals, clinics and physician offices FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016880328 EUDAMEDFDA UDI07290016880212 EUDAMEDFDA UDI
- Basic UDI-DI
- 729001688034CJ EUDAMED
- FDA Product Code
- IYN FDA 510(k)FDA UDIITX FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)FDA UDI892.1570 FDA UDI
- Market of Registration
- Poland EUDAMEDGermany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Dolphin/IQ, Dolphin/4D, and Dolphin/MAX are Transcranial Doppler (TCD) devices designed for noninvasive measurement of blood flow velocities in cerebral arteries and veins. These systems utilize ultrasound technology to assess cerebral hemodynamics, supporting clinical evaluations of conditions such as stroke risk, vasospasm, and intracranial pressure monitoring in both adult and pediatric patients.
The devices are supplied as standalone modules or paired with the Dolphin/XF robotic probe accessory for automated scanning. They are intended for single-use or reusable applications, depending on the model and configuration, and are regulated under FDA 510(k) clearance and MDR compliance. The Dolphin/XF robotic accessory enhances probe stability and reduces operator fatigue during prolonged monitoring sessions, with no specific MRI safety restrictions stated.
Frequently asked questions
What clinical conditions can the Dolphin/IQ, Dolphin/4D, and Dolphin/MAX devices help evaluate using ultrasound technology?
These devices are designed to measure blood flow velocities in cerebral arteries and veins, which helps clinicians assess conditions like stroke risk, vasospasm (narrowing of blood vessels in the brain), and intracranial pressure. By providing real-time cerebral hemodynamics data, they support evaluations in both adult and pediatric patients during critical monitoring.
How does the Dolphin/XF robotic accessory improve the user experience during prolonged monitoring sessions?
The Dolphin/XF robotic accessory is paired with the Dolphin/IQ, Dolphin/4D, or Dolphin/MAX to automate probe positioning, reducing operator fatigue and enhancing stability during extended scans. This feature ensures consistent probe placement, which is particularly useful in long-term monitoring where precision matters.
Are these devices intended for single-use or reusable applications, and how does that affect their clinical workflow?
The Dolphin/IQ, Dolphin/4D, and Dolphin/MAX can be used either as single-use or reusable devices, depending on the specific model and configuration. This flexibility allows clinicians to choose based on infection control protocols, patient volume, and workflow efficiency—whether they prioritize convenience of single-use or cost savings with reusable components.
What regulatory pathways have these devices undergone, and which advisory committee was involved in their evaluation?
The Dolphin/IQ, Dolphin/4D, and Dolphin/MAX devices, including the Dolphin/XF robotic accessory, were cleared under the FDA’s 510(k) pathway with a Traditional review and classified under the Radiology advisory committee (RA). They also comply with the Medical Device Regulation (MDR) in their respective markets, ensuring adherence to both U.S. and EU 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/MAX - Transcranial Doppler (TCD) Machine by Viasonix, Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
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 | K202742 | Class II | Active |
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Manufacturer
- Manufacturer
- Viasonix Ltd
- FDA Applicant
- Viasonix , Ltd.
Sources (5)
- FDA 510(k) K202742 24 fields · synced Sep 18, 2026
- FDA UDI 562e3cb8-1d55-47a2-9159-d2d163cb7c6b 35 fields · synced May 26, 2026
- FDA UDI a4b2c405-7b12-4108-b551-e50002f4b9c2 35 fields · synced May 30, 2026
- EUDAMED 7e666159-4491-4232-baf2-6a93b27d7b29 61 fields · synced Jul 11, 2026
- EUDAMED 2ebeff31-0ce5-4703-b7f5-baff2d6626eb 61 fields · synced Jul 27, 2026