FDA-cleared profile

Venue

GE Medical Systems

Venue provides mobile point-of-care diagnostic ultrasound; this release adds adult cNerve scouting, pediatric B-line and real-time ejection-fraction use, probe checks, catheter sizing, and workflow tools.

Ultrasound workflow

Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose: Venue provides mobile point-of-care diagnostic ultrasound; this release adds adult cNerve scouting, pediatric B-line and real-time ejection-fraction use, probe checks, catheter sizing, and workflow tools.

Intended users: Qualified and trained physicians and point-of-care ultrasound professionals.

Care setting and population: Hospitals and medical clinics, including space-constrained point-of-care settings.

Workflow role: Broad diagnostic ultrasound acquisition and measurement with automated point-of-care workflow and scouting support.

Required input: Live ultrasound from supported linear, convex, and phased-array probes plus optional ECG gating input.

Output and human action: Images, measurements, reports, DICOM studies, and release-specific nerve, B-line, ejection-fraction, and workflow outputs.

Limitations: cNerve supports adult nerve scouting before needle insertion and is not live interventional guidance. Pediatric B-line and real-time EF exclude neonates; ECG is for image synchronization, not monitoring or diagnosis.

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission: K220851

Modality: Ultrasound

Anatomy: Multi-region

Clearance type: 510(k)

Decision date: 2022-06-27

FDA status: FDA-cleared

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration: DICOM storage, archiving, printing, wireless communication, barcode and optional RFID workflows; test worklist, patient matching, archive, probe inventory, ECG gating, and role-based access.

Deployment and data flow: Mobile battery-powered ultrasound system with cleanable touch interface, articulated display, supported probes, and network options.

Security and privacy: Vendor documentation pending

Training and support: Only qualified and trained physicians and point-of-care ultrasound professionals. should operate or interpret the system. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.

Monitoring and change control: Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: cNerve supports adult nerve scouting before needle insertion and is not live interventional guidance. Pediatric B-line and real-time EF exclude neonates; ECG is for image synchronization, not monitoring or diagnosis.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K220851 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM storage, archiving, printing, wireless communication, barcode and optional RFID workflows; test worklist, patient matching, archive, probe inventory, ECG gating, and role-based access.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. cNerve supports adult nerve scouting before needle insertion and is not live interventional guidance. Pediatric B-line and real-time EF exclude neonates; ECG is for image synchronization, not monitoring or diagnosis.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: cNerve supports adult nerve scouting before needle insertion and is not live interventional guidance. Pediatric B-line and real-time EF exclude neonates; ECG is for image synchronization, not monitoring or diagnosis.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary: K220851 reports independent cNerve verification on 3,776 frames from 124 sequences contributed by 44 adults aged 18-82 across the United States, Japan, and Israel. The study used prespecified sequence and frame-detection requirements and subgroup checks; no clinical study was required.

Reported sensitivity: Not applicable

Reported specificity: Not applicable

cNerve sequences

124 sequences

Adult nerve-scouting detection in Venue.

Tested version: Venue release cleared in K220851

Source

cNerve frames

3776 frames

Frame-level nerve detection in Venue.

Tested version: Venue release cleared in K220851

Source

Successful detected-sequence criterion

80 %

Meaningfully detected sequences meeting frame criteria in Venue.

Tested version: Venue release cleared in K220851

Source

K220851 FDA performance package for Venue

Manufacturer held-out multiregion cNerve sequence and frame verification against expert annotations · 44 adults aged 18-82 across supported nerve-block locations, probes, sex, age, and BMI groups

exact submission · Tested version: Venue release cleared in K220851 · n=44 · Sponsor or vendor study

K220851

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost: Not established in reviewed sources

Reimbursement and coding: No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the device within the applicable imaging or surgical service line and verify payer, site-of-service, and coding assumptions independently.

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K220851 by exact submission identifier.

Buyer worksheet

Open questions to take to the vendor

Verify security and privacy controls: Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.
Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus

2026-09-04Last searched

24Fields reviewed

8Source classes checked

20Unreviewed PubMed leads

10Unreviewed trial leads

0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 10 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-03.

K220851 FDA decision source U.S. Food and Drug Administration · 2026-08-31
Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
Venue point-of-care ultrasound family GE HealthCare · 2026-09-03

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