Venue

K180599

GE Medical Systems Ultrasound and Primary Care Diagnostics, · cleared 2018-05-02 · product code IYN · Radiology

FDA 510(k) summary for Venue (K180599)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
4
Performance observations
0
Product code
IYN
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware
source quote (p.3)
“The Venue is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals.”
AlgorithmThe 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)
“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.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
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

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

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

25
recalls in product code, 24mo
594
MAUDE reports in code, 12mo
+95%
vs code's own 3-yr baseline
10
drift signals on this device
  • predicate_cohort_contagion

    K180599 shares predicate K170714 with K220068 (Butterfly iQ/iQ+ Ultrasound System), whose product code IYO recorded 8 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K170714 sibling:K220068

  • 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

  • …and 4 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 clinical decisions impacting overall care.

    recall event 97726 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code IYN

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Alturion Series Diagnostic Ultrasound System

K260667

Philips Ultrasound, LLC

cleared 2026-06-29

ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

K260844

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cleared 2026-06-16

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

K253595

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cleared 2026-03-27

Butterfly Gestational Age Tool

K252148

Butterfly Network, Inc.

cleared 2026-03-27

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

K260673

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-03-24

Sonio Detect (v3)

K252433

Sonio

cleared 2026-03-16

LOGIQ Totus

K253370

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-01-08

LOGIQ Fortis

K253366

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-01-07

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K180599