Venue Go

K220800

GE Medical Systems Ultrasound and Primary Care Diagnostics · cleared 2022-06-21 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The Venue Go 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. Venue Go is intended to be used in a hospital or medical clinic. Venue Go clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), Transrectal, Transvaginal, Transesophageal, Intraoperative (vascular) and interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular access). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD, B/CWD, B/Color/CWD. cNerve: may help the user to detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material.”

AlgorithmThe cNerve feature helps the user to detect and track nerves during the scouting stage of a nerve block procedure.

source quote (p.8)

“cNerve: may help the user to detect and track nerves during the scouting stage of a nerve block procedure, prior to inserting the needle to inject the anesthetic material.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

n=44 patients

endpoints: At least 70% of the sequences are meaningfully detected; At least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria)

Bench

sample size not stated

standards: AAMI/ANSI ES60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety, 2005/ A2:2012, IEC 60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2020, IEC 60601-2-37, Medical Electrical Equipment – Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015, IEC 62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2017, ISO 14971, Application of risk management to medical devices, 2019, NEMA PS 3.1 - 3.20, Digital Imaging and Communications in Medicine (DICOM) Set, 2016

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97726
re_clearance
The FDA AI/ML device list shows a newer 510(k) K251322 (decision 2025-07-25) from GE Medical Systems Ultrasound and Primary care Diagnostics, for a matching device line ("Venue; Venue Go; Venue Fit; Venue Sprint") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251322
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220851 (decision 2022-06-27) from GE Medical Systems for a matching device line ("Venue") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220851
re_clearance
The FDA AI/ML device list shows a newer 510(k) K220848 (decision 2022-06-27) from GE Medical Systems for a matching device line ("Venue Fit") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220848
recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97843
recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96992
…and 1 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).