Venue

K220851

GE Medical Systems · cleared 2022-06-27 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The proposed Venue system is a general-purpose, Track 3, diagnostic ultrasound device, intended for ultrasound imaging, measurement and analysis of the human body and fluid that provides digital acquisition, processing and display capabilities. Venue can be used in offices, clinics and hospitals. The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments. AI Summary of Testing”

AlgorithmcNerve: 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.

source quote (p.9)

“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: Sequence accuracy requirement – for testing overall cNerve performance: At least 70% of the sequences are meaningfully detected, and at least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria).

Bench

sample size not stated

endpoints: acoustic output; biocompatibility; cleaning and disinfection effectiveness; thermal, electrical, electromagnetic, and mechanical safety

standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 14971, NEMA PS 3.1 - 3.20

Reported performance (2 observations)

accuracyas written: “Sequence accuracy (meaningfully detected)”70

source quote (p.11)

“At least 70% of the sequences are meaningfully detected”

accuracyas written: “Sequence accuracy (successfully detected, meeting frame accuracy criteria)”80

source quote (p.11)

“and at least 80% of the meaningfully detected sequences are successfully detected (meeting frame accuracy criteria).”

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
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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:96992
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
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 (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95254

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).