UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

Canon Medical Systems Corporation • Radiology • 04/30/2025

510(k)IEC 62304 Class B

Device Purpose

The UltraExtend NX CUW-U001S V2.0 is an ultrasound image analysis program developed by Canon Medical Systems that enhances diagnostic capabilities by processing examination data from compatible ultrasound systems. It leverages advanced software features, including AI/ML-enabled functions like Auto EF LV, to provide comprehensive cardiac assessments such as 2D/3D Wall Motion Tracking and Cardiac4D.

Summary

The U.S. Food & Drug Administration has completed its review of the UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program, developed by Canon Medical Systems Corporation. This program, classified as a Class II medical image management and processing system, has been determined to be substantially equivalent for its stated indications for use to other legally marketed systems. Its primary function is to allow users to observe images and perform analysis based on examination data acquired from compatible diagnostic ultrasound systems. The program's design and operation are fundamentally similar to its primary comparable system, the UltraExtend FX, Ultrasound Workstation Package, sharing the same intended clinical applications. Key advancements in this new program include expanded compatibility with specific ultrasound models and enhanced software features such as advanced measurement packages, improved Cardiac4D capabilities, 2D/3D Wall Motion Tracking, and AI/ML-enabled functions like Auto EF LV. Comprehensive testing, including risk analysis, verification, validation, and performance evaluations for its AI/ML features, confirmed that these updates do not introduce new safety or effectiveness concerns, affirming the program's safety and effectiveness for its intended use.

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

UltraExtend NXUltrasound Image AnalysisCanon Medical SystemsMedical image managementDiagnostic ultrasoundAI/ML functionsCardiac4DWall Motion TrackingAuto EF LVSubstantial equivalence

Device Metadata

Submission Number

K250328

Company

Canon Medical Systems Corporation

Panel

Radiology

Product Code

N/A

Data Type

N/A

Clinical Function

N/A

AI Function

N/A

AI Subclass

N/A

Relevant Clinical Questions

Q1. What specific clinical benefits do the "advanced measurement packages" and "Cardiac4D capabilities" offer over previous versions for diagnostic accuracy?; How does the AI/ML-enabled "Auto EF LV" feature compare in accuracy and efficiency to manual or traditional methods of Left Ventricular Ejection Fraction assessment?; What are the limitations or specific types of diagnostic ultrasound systems with which the UltraExtend NX CUW-U001S V2.0 is not compatible?; Could the comprehensive testing performed on the AI/ML features be elaborated upon, specifically regarding the datasets used for validation and potential biases?; What is the workflow integration impact of this new program on existing clinical diagnostic pathways, particularly in a high-throughput environment?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Post-§524B but no clear network capability detected

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 in summary - likely in full submission per §524B

Cyber Risk Assessment⚠ Not in summary - likely in full submission per §524B

Postmarket Plan⚠ Not in summary - likely in full submission per §524B

§524B ApplicableYes

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(dataset, bias)

✓ Detected

SaaSBOMSoftware-as-a-Service Bill of Materials

- Not 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)

✓ 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 ML-BOM, OBOM detected in AI-generated device summary.

• SBOM not mentioned in AI-generated device summary. Under §524B (effective Oct 2023), cyber devices must provide a SBOM.

• Cybersecurity risk assessment not referenced in AI-generated device summary. FDA cybersecurity guidance (2023) expects this for cyber devices.

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

• Not detected in AI-generated device summary: SBOM, SaaSBOM, 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