Ultrasound Workspace (UWS 6.0)

Philips Ultrasound LLC • Radiology • 02/10/2025

510(k)IEC 62304 Class B

Device Purpose

The Philips Ultrasound Workspace (UWS 6.0) is a Class II medical image management and processing system designed to enhance diagnostic capabilities in cardiovascular, fetal, and abdominal imaging through new software applications like SWM, 3D Auto TV, and 3D Auto CFQ. Its development and marketing are based on substantial equivalence to predicate devices and validated through comprehensive non-clinical performance testing, confirming its safe and effective operation for clinical aid.

Summary

Philips Ultrasound LLC has received confirmation regarding its Ultrasound Workspace (UWS 6.0), a Class II medical image management and processing system. The device was found to be substantially equivalent to previously marketed devices for its stated indications for use, thereby permitting its marketing subject to general controls. These controls include requirements for annual registration, device listing, good manufacturing practices, and proper labeling. The UWS 6.0 introduces several new software applications and data compatibility, including Segmental Wall Motion (SWM), 3D Auto Tricuspid Valve (TV), and 3D Auto Color Flow Quantification (CFQ) features, alongside support for VeriSight ICE / Pro ICE Probe data. These additions enhance the system's capabilities for quantification and reporting of cardiovascular, fetal, and abdominal structures and function to aid diagnosis. Comprehensive non-clinical performance testing validated these new functionalities, with all predefined acceptance criteria being met. The testing confirmed that the device operates safely and effectively 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

Philips Ultrasound LLCUltrasound Workspace (UWS 6.0)Medical image managementProcessing systemSubstantial equivalenceSegmental Wall Motion (SWM)3D Auto Tricuspid Valve (TV)3D Auto Color Flow Quantification (CFQ)Cardiovascular imagingNon-clinical performance testing

Device Metadata

Submission Number

K241659

Company

Philips Ultrasound LLC

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 are expected from the new SWM, 3D Auto TV, and 3D Auto CFQ features compared to previous versions or competing systems?; What were the specific metrics and acceptance criteria used in the non-clinical performance testing, and how do they translate to real-world diagnostic accuracy?; How does the UWS 6.0's enhanced quantification capabilities improve the early detection or monitoring of cardiovascular, fetal, or abdominal pathologies?; What data compatibility limitations, if any, exist for the UWS 6.0 with older Philips ultrasound probes or systems from other manufacturers?; Are there plans for clinical trials or post-market surveillance to further assess the diagnostic impact and effectiveness of the UWS 6.0 in a diverse patient population?

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

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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 Score20/100

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✓ Detected in Summary

§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(labeling)

✓ 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

- Not 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 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.

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

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