Venue is a general-purpose diagnostic ultrasound system designed for use by qualified healthcare professionals in various clinical settings including critical care, emergency rooms, and outpatient offices. It supports multiple ultrasound imaging applications for different body regions, facilitating imaging, measurement, and analysis of human body structures and fluid, thereby aiding clinical diagnosis and interventional procedures.
Intended Use
The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals in critical care, emergency room, offices, clinical, and hospital settings for diagnosis of patients. It is for ultrasound imaging, measurement and analysis of the human body and fluid for multiple clinical applications including abdominal, thoracic/pleural, ophthalmic, fetal/OB, small organs, peripheral vascular, cephalic, pediatric, musculoskeletal, cardiac, and various interventional guidance procedures.
Technology
Venue is a general-purpose diagnostic ultrasound device using ultrasonic pulsed doppler technology with digital acquisition, processing and display capabilities. It supports various transducer types for imaging multiple body parts and clinical applications. The system features a high resolution color LCD, multi-touch user interface, battery for portable use, wireless communication, and DICOM compliance. Automated tools and biopsy kits facilitate workflow and interventional procedures.
Performance
Venue has been evaluated and found compliant with applicable medical device safety standards for acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, electromagnetic, and mechanical safety. The device passed risk analysis, unit and system verification, performance and safety testing per standards such as IEC60601-1, ISO10993-1, ISO14971, and DICOM standards. Clinical studies were not required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/7/2018
1 month - 2
FDA Approval
5/2/2018
Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics,
- Vivid Pioneer2025 • 510K
- Versana Premier; Versana Premier Lotus; LOGIQ F2024 • 510K
- Voluson Signature 20, Voluson Signature 182024 • 510K
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