UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Overview
The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program by Canon Medical Systems Corporation is a software application designed to assist physicians in analyzing and observing images from ultrasound examinations. This program supports data acquired from specific diagnostic ultrasound systems, including the TUS-AI900, TUS-AI800, TUS-AI700, and Aplio i-series (i900, i800, i700) systems.
It integrates AI/ML-enabled features for advanced cardiac analysis, such as 2D and 3D Wall Motion Tracking and Auto EF LV with Full-assist functions, aiding clinical decision-making. UltraExtend NX offers a complete offline workflow, allowing users to organize, review, analyze, document, and report clinical data efficiently, thereby freeing up the ultrasound machine for other procedures. The software leverages Canon’s raw data architecture and provides robust tools for precise cardiac quantification and planning complex procedures like THV deployment or clipping based on 3D TEE data.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-enabled advanced cardiac motion tracking and measurement
- 2D and 3D Wall Motion Tracking with Full-assist function
- Auto EF LV with Full-assist functions for cardiac analysis
- Post-processing analysis of ultrasound images
- Complete offline workflow for data organization, review, analysis, documentation, and reporting
- Leverages Canon's raw data architecture for streamlined workflow
- Precise and reproducible cardiac quantification
- Robust tools for planning complex procedures (e.g., THV deployment, clipping) based on 3D TEE data
- Integrated patient and image management system
- Connectivity options for data retrieval from ultrasound machines/NAS and sending results to PACS
Use Cases
- Analysis and observation of images from ultrasound examinations
- Aiding clinical decision-making in hospital and clinical settings
- Efficient clinical case management and follow-up
- Advanced cardiac analysis and quantification
- Planning complex cardiac procedures (e.g., Transcatheter Heart Valve (THV) deployment or clipping procedures)
- Optimizing workflow through offline image analysis
Details
| Category | Cardiology AI |
| Pricing | Contact for pricing — Contact vendor for pricing information. |
| Deployment | On-premise |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated FDA 510(k) cleared as a Class II medical device (K250328) for radiological image processing. It is intended to allow users to observe images and perform analysis based on examination data acquired using specific diagnostic ultrasound systems (TUS-AI900, TUS-AI800, TUS-AI700 and Aplio i900/i800/i700 series). |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Cardiothoracic Surgery |
What the Web Says
The UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program is a Class II medical device from Canon Medical Systems Corporation, designed for physicians and legally qualified personnel in hospital and clinical settings to observe and analyze ultrasound images. It is substantially equivalent to previous versions and other predicate devices, utilizing AI/ML algorithms for automated radiological image processing. The program is intended for use with specific Canon diagnostic ultrasound systems (TUS-AI900, TUS-AI800, and TUS-AI700) and received FDA clearance on April 30, 2025.
Overall: MixedStrengths
- Designed for use by physicians and trained personnel in clinical settings.
- Utilizes AI/ML algorithms for automated radiological image processing and analysis.
- FDA-cleared as a Class II medical device.
- Substantially equivalent to previous versions, indicating a proven technological foundation.
- Intended for use with specific Canon diagnostic ultrasound systems (TUS-AI900, TUS-AI800, and TUS-AI700).
Limitations
- Limited to use with specific Canon diagnostic ultrasound systems.
- No direct user reviews or opinions from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found in the search results.
- Information primarily from regulatory documents and product listings, not independent reviews.
- The AI/ML algorithms are nonadaptive, meaning they do not learn or change after deployment.
Based on reviews from: FDA 510(k) Premarket Notification, Innolitics (FDA Product Code Information), Canon Medical Systems (Physician AI Tools)
Last updated: 2026-07-19
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program.
Outcomes driven innovation in Ultrasound | ECR Overture 2022
Frequently Asked Questions
Compare UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
VS
VS
VS
VS
