Venue 50
by GE Medical Systems Ultrasound and Primary Care Diagnostics EUDAMED510(k)
Active
510(k) K152758
Overview
The Venue 50 is a portable diagnostic ultrasound system designed for real-time imaging of internal body structures. It employs high-frequency sound waves to generate visual images of tissues, organs, and fluids, aiding in the diagnosis and monitoring of various medical conditions such as vascular, obstetric, and abdominal assessments.
This system is intended for use in clinical, emergency, and primary care settings, providing imaging capabilities for both single-use and reusable probes. Supplied with MRI-safe components, it is available in a compact form factor for ease of transport and deployment. Authorized under FDA 510K and MDR compliance, the Venue 50 adheres to regulatory standards for diagnostic ultrasound devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK152758 | Date18 Nov 2015 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
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
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Questions
What types of medical assessments can the Venue 50 ultrasound system support in clinical settings?
The Venue 50 is designed for real-time imaging of internal structures to aid in diagnosing and monitoring conditions like vascular, obstetric, and abdominal assessments. Its high-frequency sound waves create visual images of tissues, organs, and fluids, making it versatile for a range of clinical evaluations in settings such as primary care, emergency rooms, and general diagnostic environments.
Is the Venue 50 portable, and how does its compact design benefit users?
Yes, the Venue 50 is explicitly built as a portable diagnostic ultrasound system with a compact form factor. This design allows for easy transport and deployment, making it ideal for use in mobile clinics, emergency response situations, or any setting where space or mobility is a concern.
Can the Venue 50’s probes be reused, or are they intended for single-use only?
The Venue 50 supports both single-use and reusable probes, giving clinicians flexibility depending on their workflow, infection control protocols, and patient care needs. This versatility ensures compatibility with various clinical environments and procedures.
What regulatory pathways does the Venue 50 follow, and how does that affect its use?
The Venue 50 is authorized under both FDA 510K clearance and MDR compliance, meaning it meets regulatory standards for diagnostic ultrasound systems in the United States and European markets. This ensures it adheres to safety, performance, and quality requirements for use in clinical, emergency, and primary care settings.
Does the Venue 50 include MRI-safe components, and why might that matter?
Yes, the Venue 50 is equipped with MRI-safe components, which is important for patients who may require both ultrasound imaging and MRI scans. This feature reduces the risk of interference or injury during cross-modal imaging procedures, ensuring patient safety in multi-disciplinary care settings.