Venue

GE Medical Systems Ultrasound and Primary Care Diagnostics, • Radiology • 05/02/2018

510(k)IEC 62304 Class C

Device Purpose

The GE Venue system is a mobile, general-purpose diagnostic ultrasound device designed for comprehensive imaging, measurement, and analysis across numerous clinical applications and patient types in point-of-care and hospital settings. It employs various transducers and advanced imaging modes, along with features like ECG synchronization and automated workflow tools, to enhance diagnostic capabilities and operational efficiency for healthcare professionals.

Summary

The GE Venue is a general-purpose diagnostic ultrasound system designed for use by qualified healthcare professionals in diverse clinical environments, including critical care, emergency rooms, and point-of-care settings such as offices and hospitals. This mobile system is characterized by its digital acquisition, processing, and display capabilities, a compact footprint for maneuverability in tight spaces, a high-resolution color LCD multi-touch user interface on a single, easily disinfected surface, and an articulated monitor arm for flexible display positioning. It also features battery operation for scanning without direct power, wireless communication, and a barcode reader for efficient patient data input, catering to the dynamic needs of point-of-care users. The Venue system supports a comprehensive suite of clinical applications, including abdominal (GYN and Urology), thoracic/pleural, ophthalmic, fetal/OB, small organs (breast, testes, thyroid), peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric), transrectal, transvaginal, and transesophageal imaging. It is also intended for imaging guidance of interventional procedures such as nerve blocks and vascular access. The system utilizes a variety of linear, convex, and phased array transducers to support standard acquisition modes like B-Mode, PW Doppler, CW Doppler, Color Doppler, and Power Doppler, along with combined modes and harmonic imaging. Notable technological features include ECG trace synchronization for aligning images with cardiac cycles (not for diagnostic ECG purposes), automated tools like the eFAST Navigation Tool and Review Summary feature designed to simplify and shorten workflow for specific assessments, and DICOM compliance for image storage and archiving.

AI Regulatory Concerns

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

VenueDiagnostic UltrasoundPoint-of-CareTransducersClinical ApplicationsImaging ModesECG SynchronizationInterventional GuidanceMobile UltrasoundeFAST Navigation

Device Metadata

Submission Number

K180599

Company

GE Medical Systems Ultrasound and Primary Care Diagnostics,

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. How does the performance of the new eFAST Navigation Tool compare to manual eFAST exams in terms of speed and diagnostic accuracy in emergency settings?; What is the practical impact of the added Transesophageal indication and 6Tc-RS transducer on workflow and diagnostic capabilities in cardiac care, especially concerning image quality and procedure time?; Can the automated workflow tools, beyond the eFAST exam, be customized or adapted for specific institutional protocols or individual user preferences?; What are the specific quantitative improvements (e.g., time saved, reduction in steps) provided by the enhanced automated features aimed at user workflow?; Given its point-of-care focus and battery operation, what is the typical battery life under continuous scanning conditions with demanding modes like Color Doppler, and what is the full recharge cycle time?

Risk Classification

ESL Analysis

IEC 62304 ClassC

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class C (software safety classification); Authorized before §524B enforcement

Learn how Parasoft automates IEC 62304 compliance testing →

Cybersecurity Evidence

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score10/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment⚠ Not mentioned in summary

Postmarket Plan⚠ Not mentioned in summary

§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials

- Not detected

ML-BOMMachine Learning Bill of Materials

- Not detected

SaaSBOMSoftware-as-a-Service Bill of Materials(wireless)

✓ Detected

HBOMHardware Bill of Materials

- Not detected

CBOMCryptography Bill of Materials

- Not detected

VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange

- Not detected

OBOMOperations Bill of Materials(environment, operational)

✓ Detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of SaaSBOM, OBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, ML-BOM, HBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.

Preparing a similar submission?

ESL takes complete ownership of your software evidence work - SBOM & CVE remediation with SBOMator™, static analysis & unit testing with Parasoft, traceability, and full IEC 62304 lifecycle support.

Assess Your Readiness →Or contact ESL directly