GE Medical Systems Ultrasound and Primary Care Diagnostics · Class II · Cleared Jul 25, 2025
| K-number | K251322 |
| Device name | Venue; Venue Go; Venue Fit; Venue Sprint |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product code | IYN |
| Device class | Class II |
| Decision date | Jul 25, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
The Venue, Venue Go, Venue Fit, and Venue Sprint are general-purpose diagnostic ultrasound systems for qualified healthcare professionals to perform ultrasound imaging, measurement, and analysis of the human body and fluids. Venue, Venue Go, and Venue Fit are used in hospitals or medical clinics for applications including abdominal, cardiac, vascular, obstetric, and interventional guidance. Venue Sprint is additionally designed for use in home environments and ambulances.
The proposed devices employ the same fundamental scientific technology as their predicates. Key differences include: addition of Thoracic/Pleural application on existing C2-9-RS probe; addition of PDI+ imaging mode on existing linear and convex probes; addition of cNeedle feature; expansion of Caption Guidance for Vscan Air SL probe; image quality improvements via postprocessing and display parameters without changing core beamforming; addition of Automated Function Imaging (AFI) with AI Auto ROI algorithm; and addition of Auto Bladder Volume (ABV) using deep learning instead of traditional image analysis.
The devices comply with AAMI/ANSI ES60601-1:2005/A2:2021, IEC 60601-1-2:2020, IEC 60601-2-37:2015, IEC 62359:2017, ISO 10993-1:2018, ISO 14971:2019, NEMA PS 3.1-3.20e:2023, and AAMI TIR69:2020. Venue Sprint additionally complies with IEC 60601-1-11:2020 and IEC 60601-1-12:2020 for home healthcare and emergency medical services environments.
Substantial equivalence is supported by: identical indications for use and imaging modes between proposed and predicate devices; same fundamental ultrasound technology; identical transducers for Venue Sprint and predicate Venue Sprint; similar transducers with minor application/feature additions for Venue/Go/Fit; new features (AFI, ABV, Caption Guidance expansion) that are either already cleared on reference devices or represent postprocessing/display improvements without altering core imaging physics; conformance to applicable medical device safety standards; and no changes to input parameters (power/frequency) or core beamforming architecture.
View the full FDA submission: accessdata.fda.gov