Venue
K180599GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2018-05-02 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals.”
source quote (p.15)
“The system includes several automated tools designed to simplify and shorten the workflow time of the healthcare professional for some common assessments. Adding eFAST Navigation Tool and Review Summary feature that automates the workflow for the eFAST exam that can be done manually.”
source quote (p.15)
“System meets DICOM requirements to support users image storage and archiving needs and allows for output to printing devices. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2016”
Validation studies (1)
Bench
sample size not stated
standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K220800 (decision 2022-06-21) from GE Medical Systems Ultrasound and Primary Care Diagnostics for a matching device line ("Venue Go") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K220800
- 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
- …and 2 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).