EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound LLC • Radiology • 04/10/2025

510(k)IEC 62304 Class B§524B Cyber Device

Device Purpose

This determination facilitates the marketing of Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems, now equipped with an enhanced Remote Software Management (RSM) feature designed to enable comprehensive remote system upgrades, including operating system components and drivers. The methodology involved solely software modifications, validated through non-clinical performance data to ensure the sustained safety and effectiveness of the devices.

Summary

On April 10, 2025, a determination was issued to Philips Ultrasound LLC concerning their EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System. Following a review, these systems were deemed substantially equivalent to previously marketed devices for their stated indications for use. This allows Philips Ultrasound LLC to market the systems, subject to general controls including annual registration, device listing, good manufacturing practices, and accurate labeling. The core of the submission focused on introducing an enhanced Remote Software Management (RSM) feature to the ultrasound systems. This upgraded software capability allows for comprehensive remote system upgrades, encompassing operating system components, various drivers, and application packages, in addition to supporting automatic and scheduled software downloads and installations. This expands upon previous RSM capabilities that were limited to patch upgrades. The modifications involved no hardware changes, and non-clinical performance data confirmed that the new feature maintains the devices' safety and effectiveness.

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 LLCEPIQ SeriesAffiniti SeriesDiagnostic Ultrasound SystemSubstantial equivalenceRemote Software ManagementSoftware upgradesOperating system componentsNon-clinical performance dataDevice safety and effectiveness

Device Metadata

Submission Number

K250177

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 cybersecurity measures are implemented within the enhanced Remote Software Management feature to protect patient data and system integrity during remote upgrades?; How does the enhanced RSM feature's ability to upgrade operating system components and drivers affect the validation process for clinical use cases, especially concerning system stability and image quality?; Are there any bandwidth or network requirements for the enhanced RSM feature to ensure reliable and efficient remote software installations, particularly in clinical settings with varying internet access?; What is the rollback procedure or contingency plan if a remote software upgrade fails or introduces unforeseen issues during a critical clinical operation?; Beyond non-clinical performance data, what post-market surveillance or real-world evidence collection is planned to monitor the long-term impact of comprehensive remote software management on device performance and reliability?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Qualifies as a cyber device under §524B (post-Dec 2023, networked)

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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 Score50/100

SBOM Evidence⚠ Not in summary - likely in full submission per §524B

Cyber Risk Assessment✓ Detected in Summary

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(remote, internet, network)

✓ Detected

HBOMHardware Bill of Materials(hardware)

✓ 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, SaaSBOM, HBOM 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.

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

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