Voluson™ Performance 16

by GE HealthCare  · Based in United States → — Delivering detailed imaging and simplified workflow with AI and automation for women's health.
Maternal-Fetal Medicine Obstetrics & Gynecology Radiology
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Regulatory Status Disclosed

Overview

The Voluson™ Performance 16 is an advanced ultrasound system from GE HealthCare, designed specifically for women’s health applications including obstetrics, gynecology, and general imaging. It is part of the Voluson Performance series, which integrates artificial intelligence (AI) and automation tools to enhance image quality, streamline workflows, and reduce exam times. Key features include the SonoLyst suite, which provides AI-powered automated annotations and measurements of fetal anatomy, potentially reducing exam time for ISUOG second-trimester exams by up to 65%. The system also incorporates technologies like Autolive for automatic gain adjustments, Shadow Reduction for improved image uniformity, and a comprehensive probe portfolio for exceptional 2D and 3D imaging. It features an updated touch panel interface, integrated wireless Vscan Air probes for convenient bedside scanning, and voice-activated controls for hands-free operation. The Voluson Performance 16 is built to provide high-performance ultrasound imaging and analysis, with comprehensive networking and DICOM capabilities for seamless data exchange.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • SonoLyst suite with AI-powered automated annotations and measurements of fetal anatomy
  • Up to 65% reduction in exam time for ISUOG second trimester exams with AI features
  • Autolive for automatic gain adjustments and improved image uniformity
  • Shadow Reduction for enhanced image quality in challenging conditions
  • Comprehensive probe portfolio for 2D and 3D/4D imaging
  • Updated touch panel interface for intuitive workflow
  • Integrated wireless Vscan Air probes for bedside scanning and interventional use
  • Voice-activated 'Hey Voluson' feature for hands-free control
  • DICOM standard compliance for seamless data exchange
  • Hard Drive (HD) encryption and Encrypted DICOMu00ae Communication Capability (TLS) for data security

Use Cases

  • Obstetric examinations and fetal assessment
  • Gynecological imaging and diagnosis
  • Women's health screening and monitoring
  • Real-time 3D/4D acquisition
  • General diagnostic ultrasound imaging
  • Pelvic floor assessment (with SonoPelvicFloor3.0)

What Physicians Need to Know

Fetal Monitoring AI
The Volusonu2122 Performance 16 features the SonoLyst suite of AI tools, which automatically identifies fetal anatomy, annotates standard views, and automates measurements, potentially reducing keystrokes for routine second-trimester exams by up to 65%. SonoLystlive enables real-time image capture for dynamic fetal assessment. Additionally, the system integrates with Diagnoly's Fetolyu2122 solution, offering real-time AI-powered clinical diagnostic support for comprehensive fetal heart and brain analysis, and continuously verifies exam completeness and quality criteria.
Ultrasound Image Analysis
AI and automation tools are built into the Volusonu2122 Performance 16 to simplify measurements, anatomy identification, and reporting. Features like AutoLive provide automatic gain adjustments for improved image uniformity, and Shadow Reduction aims to deliver clear and consistent imaging. SonoPelvicFloor uses guided workflow and AI to help achieve consistent, reproducible pelvic exam results up to 75% faster. The system also includes Auto Caliper for simplified ovarian follicle measurement and Fibroid Mapping for 3D fibroid documentation.
IVF Support Tools
The Volusonu2122 Performance 16 offers an Auto Caliper feature for simplified ovarian follicle measurement, which is crucial for IVF workflows. It also includes a Follicle Monitoring Package to support reproductive medicine practices.
Prenatal Testing Integration
The Volusonu2122 Performance 16's advanced imaging capabilities, including high-resolution 2D, 3D, and 4D, support early detection of chromosomal and structural anomalies, complementing prenatal screening tests like NIPT. The integration of Diagnoly's Fetolyu2122 solution directly provides AI-driven prenatal screening support for fetal heart and brain analysis.
Labor & Delivery Support
The system offers a Labor & Delivery Package and includes Sono-L&D, which utilizes transperineal ultrasound to help assess fetal station through measurements and provides an animation of fetal head progression. Sono-L&D also facilitates electronic documentation of the labor process, combining ultrasound data and manual exam results.
Physician Tip

Leverage the SonoLyst suite for automated fetal anatomy recognition and measurements to significantly reduce exam time and enhance consistency in second-trimester screenings. Utilize Auto Caliper and the Follicle Monitoring Package for efficient and precise follicle assessment in reproductive medicine. Employ SonoPelvicFloor for standardized and faster pelvic floor evaluations. Integrate the voice-activated 'Hey Voluson' feature and updated touch panel for hands-free control and streamlined workflows, allowing more focus on patient interaction. Explore the Voluson Solution Store for additional AI applications like Diagnoly's Fetolyu2122 to further enhance fetal cardiac and brain analysis.

The Volusonu2122 Performance 16 is designed with comprehensive networking and DICOM capabilities, enabling seamless sharing of medical information with other digital imaging systems and information systems for worklist downloads, image storage, and reporting. It supports integration with wireless Vscan Air probes for convenient bedside scanning and interventional use. The system also offers remote service for clinical and technical support, and continuous updates and upgrades to ensure lasting value and access to new innovations. The Voluson Solution Store serves as a digital marketplace for integrating additional AI-driven solutions, such as Diagnoly's Fetolyu2122 for advanced fetal assessments.

Details

Category OB/GYN AI
Pricing Contact for pricing — Contact GE HealthCare sales for customized configurations and pricing.
DeploymentOn-premise hardware
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Yes AI-estimated

The Voluson™ Performance 16 received U.S. FDA 510(k) clearance (K250543) on February 24, 2025, as an Ultrasonic Pulsed Doppler Imaging System (Class II), indicating it is substantially equivalent to legally marketed predicate devices.
Integrations
EHR Not specified
Specialties Maternal-Fetal Medicine, Obstetrics & Gynecology, Radiology

What the Web Says

The GE Volusonu2122 Performance 16 is a women's health ultrasound system that emphasizes streamlined scanning through high-resolution imaging, advanced tools, and intuitive design. It incorporates AI and automation to simplify measurements, anatomy identification, and reporting, aiming to save time and reduce user fatigue. The system is designed to provide efficient and consistent care delivery, building on GE Healthcare's legacy of innovation in ultrasound technology.

Overall: Positive

Strengths

  • High-resolution imaging and detailed imaging capabilities.
  • Intuitive design and user-friendly interface.
  • AI and automation tools (SonoLyst, SonoPelvicFloor, SonoAVCfollicle, Fibroid Mapping, Auto Caliper) simplify measurements, identification, and reporting.
  • Can significantly reduce exam time, with up to a 65% reduction for ISUOG second-trimester exams.
  • Features like Autolive and Shadow Reduction enhance image quality and uniformity.
  • Offers continuous remote updates and upgrades, and access to educational content through the Voluson Club.

Limitations

  • No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
  • The Voluson Performance series has less processing power and image-rendering capabilities compared to the Voluson Expert Series.
  • Does not include the B-Flow mode, which is present in some other Voluson systems.

Based on reviews from: GE HealthCare Introduces Next Evolution of AI-enabled Voluson Performance Series, Search FDA-cleared listings - Radiology AI Tools Directory, GE Medical Systems Ultrasound and Primary care Diagnostics, LLC Bryan Behn Senior Regulatory Affairs Director - accessdata.fda.gov, GE HealthCare Launches AI-Powered Voluson Performance 18 and 16 Ultrasound Systems, What is the Difference Between the Voluson Performance Series and Signature Series?, Volusonu2122 Performance series - GE Healthcare

Last updated: 2026-07-19

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Press & Coverage

GE HealthCare
GE HealthCare Launches AI-Powered Voluson Performance 18 and 16 Ultrasound Systems
GE HealthCare has launched its AI-powered Voluson Performance 18 and 16 ultrasound systems, featuring automated annotations and measurements that can reduce exam time by up to 65% for the ISUOG second trimester exam.
2025-09
GE HealthCare
GE HealthCare launches AI-powered Voluson Performance 18 & 16 ultrasound
The Voluson Performance series, including the 18 and 16 models, integrates AI and automation tools to provide detailed imaging and simplify workflows for women's health applications.
2025-09
FDA
K250543 - 510(k) Premarket Notification - FDA
The FDA issued a 510(k) premarket notification for the Volusonu2122 Performance 16 and Volusonu2122 Performance 18, indicating their substantial equivalence to predicate devices for diagnostic ultrasound imaging.
2025-05
GE HealthCare
GE HealthCare Launches AI-Enabled Ultrasound Series for Women's Health
GE HealthCare's new Voluson Performance series, including the 18 and 16, integrates AI and automation for detailed imaging and simplified workflows in women's health, featuring tools like AutoLive and SonoLyst.
2025-09
24X7mag
GE HealthCare Launches AI-Enabled Ultrasound Series for Women's Health - 24X7mag
The Voluson Performance 18 and 16 models have received US FDA 510(k) clearance and CE Marking, and are designed to enhance workflow efficiency and accuracy in women's health through AI and automation.
2025-09
GE HealthCare
GE HealthCare Launches AI-Enabled Voluson Ultrasound Systems
GE HealthCare's Voluson Performance 18 and 16 ultrasound systems combine high-resolution imaging with AI-powered automated workflows to improve women's health diagnostics and address the global challenge of maternal mortality.
2025-10
GE HealthCare
Voluson Performance 16 - image
The Voluson Performance 16 offers a compact design, intuitive workflow, and powerful imaging capabilities with features like one-touch optimization, Autolive for image uniformity, and voice control.
2025-08
FDA
Search FDA-cleared listings - Radiology AI Tools Directory
The Volusonu2122 Performance 16 and 18 are listed in the FDA-cleared Radiology AI Tools Directory, indicating their authorization for image analysis/processing in ultrasound.
2025-05

Videos

Product demos, reviews, and walkthroughs for Voluson™ Performance 16.

View all on YouTube

Frequently Asked Questions

The Voluson Performance 16 integrates AI tools like SonoLyst, which automates fetal anatomy identification, annotation, and measurements, potentially reducing second-trimester exam time by up to 65%. It also features SonoPelvicFloor for guided workflows and 'Hey Voluson' for voice-activated control, streamlining various aspects of the examination process.
The Voluson Performance 16, including its AI-powered features, has received U.S. FDA 510(k) clearance and is CE Marked, indicating compliance with relevant medical device regulations. It also conforms to DICOM standards for sharing medical information, which is crucial for data management and interoperability.
While the Voluson Performance 16 is specialized for women's health, other manufacturers offer AI-enabled ultrasound systems. Competitors like Siemens Healthineers (ACUSON Origin), Philips (Affiniti, EPIQ), Samsung (HERA line), and Mindray also integrate AI for enhanced image quality, workflow efficiency, and diagnostic support across various specialties.
While specific pricing for the Voluson Performance 16 isn't explicitly stated, new high-end Voluson systems can range from $45,000 to $65,000, with refurbished models typically between $25,000 and $40,000. The AI features aim to provide value by improving workflow efficiency, reducing exam times, and enhancing diagnostic consistency, potentially leading to increased patient throughput and better outcomes.
Limitations of AI in ultrasound include reduced accuracy with poor-quality images (e.g., due to high maternal BMI or fetal position) and the need for extensive training data, especially for rare anomalies. AI also functions as a support tool, not a replacement for human expertise, and its effectiveness can still be influenced by operator technique and the interactive nature of ultrasound exams.
GE HealthCare continuously strengthens its AI offerings, as evidenced by collaborations like the one with Diagnoly to integrate solutions such as Fetoly for advanced fetal heart and brain analysis. The Voluson series is designed with flexible, scalable software, allowing for future AI enhancements and software upgrades to keep the technology current.
The AI and automation tools, such as SonoLyst and 'Hey Voluson' voice control, are designed to simplify measurements, identify anatomy, and reduce keystrokes, thereby decreasing user fatigue and streamlining exams. This can support clinicians across various experience levels, potentially reducing the learning curve for new users while enhancing efficiency for experienced ones.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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