Venue Fit
GE Medical SystemsVenue Fit is a compact, portable diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-quality ultrasound imaging and fluid flow analysis across multiple clinical applications. The system supports standard ultrasound modes and includes AI-assisted features such as nerve tracking to help clinicians during procedures. Venue Fit enhances imaging capabilities and workflow efficiency in hospital and clinical settings.
Intended Use
The Venue Fit 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.
Technology
The Venue Fit is a compact, portable diagnostic ultrasound device utilizing a variety of linear, convex, and phased array transducers for high imaging capability. It supports all standard ultrasound modes and incorporates AI-based features such as the cNerve tool for nerve detection and tracking during nerve block procedures. It supports DICOM for image storage and can connect wired or wirelessly to hospital networks.
Performance
The device underwent extensive non-clinical safety testing meeting medical electrical and ultrasound safety standards. AI feature cNerve was validated on a test dataset covering 44 individuals and 124 imaging sequences with 3776 frames. Performance criteria based on accuracy of nerve detection in frames and sequences were met. Clinical testing was not required to demonstrate substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/23/2022
3 months - 2
FDA Approval
6/27/2022
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