Venue
GE Medical SystemsVenue by GE Medical Systems is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It offers ultrasound imaging, measurement, and analysis of the human body and fluids in a variety of clinical settings including hospitals and clinics. The device supports multiple clinical applications across different body regions and features automated tools to improve clinical workflow. Venue also includes AI-powered tools such as cNerve which assists in nerve detection and tracking during nerve block procedures, enhancing precision and patient safety.
Intended Use
The Venue is a general purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, intended to be used in a hospital or medical clinic with multiple clinical applications including abdominal, thoracic/pleural, ophthalmic, fetal/OB, small organ, vascular, neonatal and adult cephalic, pediatric, musculoskeletal, cardiac, transrectal, transvaginal, transesophageal, intraoperative and interventional guidance.
Technology
Venue is a mobile, general purpose diagnostic ultrasound system using linear, convex, and phased array transducers, offering multiple ultrasound modes including B, M, PW Doppler, CW Doppler, Color Doppler variations, Power Doppler, Harmonic Imaging, and Coded Pulse. It includes automated tools to assist user workflow and AI-powered tools such as cNerve for nerve detection and tracking. The device supports ECG synchronization, wireless communication, and DICOM standards for image storage and output.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety testing, complying with relevant international safety standards. AI performance of the cNerve tool was validated on a dataset of 124 sequences from 44 individuals showing appropriate accuracy for the intended use. Clinical studies were not required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/23/2022
3 months - 2
FDA Approval
6/27/2022
Other devices from GE Medical Systems
- SIGNA MAGNUS2024 • 510K
- Sonic DL2023 • 510K
- Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite2023 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.