SuperSonic HepaVu
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SuperSonic HepaVu EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- SuperSonic HepaVu EUDAMEDFDA UDI
- Model / Reference
- ASY-HEPA-INTL EUDAMEDFDA UDI
- Description
- SuperSonic HepaVu FDA UDI
Identifiers
- Catalog Number
- ASY-HEPA-INTL FDA UDI
- Primary DI / UDI-DI
- 03760193600384 EUDAMEDFDA UDI
- Basic UDI-DI
- 376019360HepaVuYH EUDAMED
- 510(k) Number
- FDA Product Code
- IYN FDA 510(k)FDA UDIITX FDA UDIIYO FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) 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 UDI892.1560 FDA UDI
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- 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
Yes
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 SuperSonic HepaVu is a contrast-enhanced ultrasound imaging device designed for visualizing blood vessels and tissue perfusion. It employs microbubble contrast agents to enhance ultrasound imaging, improving the detection and assessment of vascular structures and abnormalities within soft tissues.
This device is intended for use in clinical settings such as radiology departments and is supplied as a reusable system. It operates under FDA 510K clearance and MDR authorization, adhering to regulatory standards for medical imaging equipment. The device is not classified as single-use and requires proper maintenance and storage as per manufacturer guidelines to ensure optimal performance and safety.
Frequently asked questions
What clinical scenarios is the SuperSonic HepaVu primarily used for in radiology departments?
The SuperSonic HepaVu is designed to enhance ultrasound imaging by using microbubble contrast agents, making it particularly useful for visualizing blood vessels and assessing tissue perfusion. Clinicians may use it to improve detection and evaluation of vascular abnormalities, such as tumors, liver lesions, or vascular malformations, in soft tissues. Its contrast-enhanced capabilities help differentiate blood flow and tissue characteristics more clearly than standard ultrasound.
Is the SuperSonic HepaVu a single-use device, or can it be reused in multiple procedures?
The SuperSonic HepaVu is explicitly described as a reusable system, not a single-use device. Like other reusable medical imaging equipment, it requires proper maintenance, cleaning, and storage as outlined by the manufacturer to ensure safety, performance, and compliance with regulatory standards. Reuse is only possible under the manufacturer’s guidelines and maintenance protocols.
How is the SuperSonic HepaVu regulated, and what does its FDA 510K clearance mean for users?
The SuperSonic HepaVu holds FDA 510K clearance, meaning it has been determined to be *substantially equivalent* to a legally marketed device already on the market. This classification ensures it meets U.S. safety and performance standards for contrast-enhanced ultrasound imaging systems. Clinicians and buyers can rely on this clearance as evidence of regulatory review, though they should always follow the manufacturer’s instructions for use and maintenance.
What type of maintenance or storage requirements should be followed for the SuperSonic HepaVu?
Since the SuperSonic HepaVu is a reusable device, it must be maintained and stored according to the manufacturer’s guidelines to preserve functionality and sterility. Proper cleaning, calibration, and storage conditions are critical to prevent contamination or performance degradation. The manufacturer’s instructions—likely included in the device documentation—will specify cleaning protocols, storage environments, and any periodic servicing needed to comply with regulatory and safety 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.
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 | K242223 | Class II | Active |
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Manufacturer
- Manufacturer
- Supersonic Imagine
Sources (3)
- FDA 510(k) K242223 24 fields · synced Sep 18, 2026
- FDA UDI 06a05e4d-4580-4d6b-8285-7f672675a49c 36 fields · synced May 30, 2026
- EUDAMED e87ec4a9-e9da-45d3-a6f8-f698c16cd67a 61 fields · synced Jul 27, 2026