Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultraso…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243298 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 Venus Ultimate-Dual, Venus Ultimate-Hepa, and Venus Ultimate-Uro are diagnostic ultrasound systems designed for medical imaging. These devices utilize ultrasound technology to generate real-time visuals of internal body structures, aiding in the diagnosis of conditions across multiple specialties, including vascular, hepatobiliary, and urological assessments.
These systems are intended for use in clinical settings such as hospitals, diagnostic centers, and outpatient clinics. They are supplied as reusable medical devices and comply with regulatory standards including FDA 510(k) clearance and MDR authorization. The Venus Ultimate series is categorized under product code IYN and is intended for professional medical imaging applications, adhering to safety and performance requirements for diagnostic ultrasound equipment.
Frequently asked questions
What specialties are these ultrasound systems primarily designed to support in clinical practice?
The Venus Ultimate-Dual, Venus Ultimate-Hepa, and Venus Ultimate-Uro systems are engineered to assist in vascular, hepatobiliary (liver and bile duct), and urological assessments respectively. Their real-time imaging capabilities help clinicians visualize internal structures for diagnostic purposes across these specialties in settings like hospitals, diagnostic centers, and outpatient clinics.
Are these devices single-use or reusable, and how does that affect their use in a clinical setting?
The Venus Ultimate series is explicitly designed as a reusable medical device, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. This makes them suitable for high-volume clinical environments like hospitals and diagnostic centers, where durability and cost-effectiveness are priorities for professional medical imaging applications.
What regulatory pathways have these ultrasound systems undergone, and what does that mean for their use?
The Venus Ultimate systems have undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming they meet U.S. and EU safety and performance standards for diagnostic ultrasound equipment. This means they are legally marketable in those regions for professional medical imaging, adhering to strict regulatory requirements for reusable devices in clinical settings.
How do I determine which model is best suited for my specific clinical needs?
The Venus Ultimate series is differentiated by specialty focus: the Venus Ultimate-Dual is likely designed for general vascular and multi-specialty use, while the Venus Ultimate-Hepa and Venus Ultimate-Uro are tailored for hepatobiliary and urological assessments, respectively. Reviewing your facility’s most common diagnostic needs—such as liver imaging or urinary tract evaluations—will help select the model that aligns with your workflow and patient population.
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: Venus • einfach erklärt, Steckbrief, Temperatur · [mit Video], Venus: Facts - NASA Science
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 | K243298 | Class II | Active |
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Manufacturer
- Manufacturer
- Carbon (Shenzhen) Medical Device Co., Ltd.
Sources (2)
- FDA 510(k) K243298 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026