EchoPAC Software Only, EchoPAC Plug-In

GE Medical Systems Ultrasound and Primary Care Diagnostics • Radiology • 09/18/2020

510(k)IEC 62304 Class B

Device Purpose

The EchoPAC Software Only / EchoPAC Plug-in is a specialized software solution designed for physicians to perform comprehensive review, analysis, and management of ultrasound images obtained from GE systems and DICOM sources. It utilizes post-processing of data from diverse ultrasound modes (2D, 3D/4D, Doppler) to support diagnostic capabilities across a wide range of clinical applications.

Summary

The EchoPAC Software Only / EchoPAC Plug-in is a medical software system intended for use by, or on the order of, a licensed physician for the diagnostic review and analysis of ultrasound images, patient record management, and reporting. It enables post-processing of raw data images acquired from GE ultrasound scanners and standard DICOM ultrasound images, enhancing the diagnostic information available to clinicians. The software supports a comprehensive range of ultrasound imaging modes, including B (2D), M, Color M, Color, Power, Pulsed and Continuous Wave (CW) Doppler, Coded Pulse, Harmonic, 3D, and Real-time 3D (4D) modes. Its versatility allows for broad clinical application across numerous specialties such as Fetal/Obstetrics, Abdominal (including renal and GYN), Urology (including prostate), Pediatric, Small Organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal (conventional and superficial), Transrectal, Transvaginal, Intraoperative (vascular), Intra-cardiac, and Intra-luminal examinations.

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

Ultrasound Image AnalysisPatient Record ManagementDiagnostic Review SoftwarePost-processingDICOMGE Ultrasound ScannersMulti-modal Ultrasound Imaging (2D3D4DDoppler)Cardiac UltrasoundObstetrical UltrasoundVascular Ultrasound

Device Metadata

Submission Number

K200852

Company

GE Medical Systems Ultrasound and Primary Care Diagnostics

Panel

Radiology

Product Code

N/A

Data Type

Images

Clinical Function

Assessment

AI Function

Analysis

AI Subclass

quantification/feature localization

Relevant Clinical Questions

Q1. What specific quantitative analysis tools are available within EchoPAC for advanced applications like strain imaging in cardiology or volumetric measurements in obstetrics, and what is their validated accuracy?; How does the EchoPAC software handle and optimize the processing of large raw data files from real-time 3D (4D) ultrasound acquisitions, particularly concerning processing speed and image fidelity?; Beyond basic DICOM compatibility, what are the integration capabilities of EchoPAC with various vendor-neutral archives (VNAs) and electronic health record (EHR) systems for seamless workflow?; Are there built-in reporting templates customizable for different clinical applications, and do they support the inclusion of standardized lexicon or measurements (e.g., BI-RADS, PI-RADS)?; What are the comparative advantages of the EchoPAC Plug-in version versus the Software Only version in terms of features, performance, and deployment in diverse clinical IT environments?

Risk Classification

ESL Analysis

IEC 62304 ClassB

FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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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 Score5/100

SBOM Evidence⚠ Not mentioned in summary

Cyber Risk Assessment⚠ Not mentioned in summary

Postmarket Plan⚠ Not mentioned in summary

§524B ApplicableNo

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

- Not 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(deployment, 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 OBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

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

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

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