X9 Ultrasound System

by X9, Inc.  · Based in United States → — A scalable, single-handed, point-of-care platform integrating real-time AI-powered ultrasound imaging with micro-level precision.
Interventional Radiology Nephrology Vascular Surgery

Contact for pricing
Regulatory Status Disclosed

Overview

The X9 Ultrasound System is an innovative medical device developed by X9, Inc. It is designed as a handheld, point-of-care platform that integrates real-time AI-powered ultrasound imaging with micro-level precision. The system consists of a handheld device with an ultrasound transducer connected via a cable to a user-supplied computer. Its primary purpose is to assist healthcare providers in confidently performing delicate procedures by offering real-time navigation and imaging guidance. The device aims to reduce variability, enhance procedural accuracy, and streamline workflows, ultimately supporting lower complication rates and improved patient outcomes. It is engineered for interoperability, capable of securely transmitting critical data to existing platforms and EMRs, and supports automated measurements, alerts, and reporting. The X9 Ultrasound System also features integrated AI health monitoring for continuous data collection, enabling early detection of complications and proactive management through secure remote access and predictive analytics.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-guided ultrasound imaging for real-time navigation
  • Micro-level precision for delicate procedures
  • Single-handed point-of-care platform
  • Automated data capture and reporting
  • Reduced variability and enhanced procedural accuracy
  • Ecosystem integration with existing platforms and EMRs
  • Continuous AI health monitoring and predictive analytics
  • Handheld device with ultrasound transducer and software
  • Streamlined workflows and minimized training requirements

Use Cases

  • Guidance for vascular access in hemodialysis
  • Assistance with biopsies
  • Support for nerve blocks
  • Guidance for tumor ablations
  • General interventional procedures
  • Point-of-care diagnostics in diverse environments

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing — N/A
DeploymentOn-premise (device-based, connected to user-supplied computer)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The X9 Ultrasound System received FDA 510(k) clearance (K251673) on October 17, 2025. It is intended for ultrasound imaging of validated vascular accesses for hemodialysis during the preliminary stage of a cannulation procedure, prior to inserting the needle. The device is for use by qualified healthcare professionals in a medical setting and is not intended for pediatric patients or to diagnose vessel position without confirmation.

Integrations
EHR Not specified
Specialties Interventional Radiology, Nephrology, Vascular Surgery

What the Web Says

The Esaote MyLab X9 is a high-performance ultrasound system designed for a variety of clinical applications, offering advanced imaging technologies and user-friendly features. It is praised for its high-quality imaging, user-friendly interface, and versatility across multiple specialties. The system also offers advanced features like QElaXtou2122 for elastography, XView+ for image enhancement, and 3D/4D imaging.

Overall: Positive

Strengths

  • High-quality imaging for detailed and accurate diagnostics
  • User-friendly interface and ergonomic design
  • Versatile for multiple specialties and clinical applications
  • Advanced imaging technologies like QElaXtou2122, XView+, and 3D/4D
  • Enhanced vascular imaging for detailed blood flow studies
  • Portability, making it ideal for point-of-care settings

Limitations

  • No specific cons were identified in the provided search results.
  • Compared to console-based machines, portable systems may not offer the same image quality

Based on reviews from: Faculty of Medicine, MedTech Dive, Marcroft Medical, Reddit

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

GlobeNewswire
X9, Inc. Announces Successful Completion of First-in-Human Feasibility Study for Ultrasound-Guided, Power-Assisted Needle Insertion Device in Hemodialysis Cannulation
X9, Inc. announced positive results from its first-in-human clinical feasibility study for the X9 Ultrasound System with Power-Assisted Needle Insertion, a device designed to simplify ultrasound-guided needle insertion in hemodialysis patients. The study validated the platform's potential to improve vascular access by enabling precise vessel alignment and accurate needle placement using real-time, machine learning-assisted vessel alignment.
2025-11
Constat
X9 Ultrasound System (K251673) u2014 FDA 510(k) evidence
The X9 Ultrasound System, manufactured by X9, Inc., received FDA 510(k) clearance on October 17, 2025, under product code SGH for Radiology.
2025-10
accessdata.fda.gov
X9 Ultrasound System
The FDA document details the X9 Ultrasound System's intended use for ultrasound imaging of validated vascular accesses for hemodialysis during the preliminary stage of a cannulation procedure, prior to inserting the needle. It also specifies that the device is not for use in pediatric patients.
2025-10
Nyquist AI Blog
Data Update: November 2025
This blog post mentions the X9 Ultrasound System (SGH) in its November 2025 data update, which covers FDA device approvals and regulatory updates.
2025-11
RAD Magazine
Diana, Princess of Wales Hospital adds MyLab X9 ultrasound system
Diana, Princess of Wales Hospital in Grimsby, UK, acquired Esaote's MyLab X9 ultrasound system to enhance breast unit diagnostics with high-quality imaging and advanced technologies like QElaXto 2D. The system aims to improve cancer detection and patient care for approximately 500-600 new referrals monthly.
2022-01
Coherent Market Insights
Interventional Radiology Market Size and Forecast, 2026-2033
This market analysis report mentions Esaote's launch of the MyLab X9 ultrasound system in May 2021, highlighting its advanced X ULTRA technology for high image quality and data processing.
2026-03
Barco
Customized display pushes performance boundaries in ultrasound imaging
Barco collaborated with Esaote to provide a customized 24-inch display for the new Esaote MyLab X9 ultrasound system, offering sharp, bright images with high contrast and a wide viewing angle. The display features LED backlight technology for sustained brightness and a front consistency sensor for continuous luminance stability.
2021-05
Esaote
Ultrasound Systems: from console to portable units
Esaote showcases its MyLab X9 ultrasound system as an expert system delivering top-class image quality even in challenging cases, featuring AI-based technologies, interventional capabilities, frequency probes up to 25 MHz, and a 24-inch Barco monitor.
2026-07

Videos

Product demos, reviews, and walkthroughs for X9 Ultrasound System.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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