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EchoPAC Software Only

by GE Medical Systems Ultrasound and Primary Care Diagnostics LLC United States 510(k)

510(k) K200852

Product code LLZ

Overview

The EchoPAC Software Only is a software solution that supports exam reviews, post-exam interpretation, reporting, and archiving. It is designed to enhance cardiac patient care by allowing measurements and diagnosis to be performed using 2D and 4D images, either on-site or remotely.

The EchoPAC Software Only is supplied as a software only solution and is intended for use in a clinical setting. It has received FDA 510K authorization and is classified under product code LLZ. The software is available in various versions, including v202.74.0, and is supported by GE HealthCare.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200852 Date18 Sep 2020ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
LLZ
FDA applicant
GE Medical Systems Ultrasound and Primary Care Diagnostics
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the EchoPAC Software Only used for in clinical settings?

    The EchoPAC Software Only is designed to support cardiac patient care by enabling detailed exam reviews, post-procedure interpretation, and reporting using 2D and 4D ultrasound images. Clinicians can perform measurements and diagnoses either on-site or remotely, improving diagnostic accuracy and workflow efficiency for cardiac evaluations.

  • Is the EchoPAC Software Only a standalone product or does it require additional hardware?

    The EchoPAC Software Only is supplied exclusively as a software solution and does not require additional hardware beyond a compatible clinical ultrasound system. It integrates with existing imaging equipment to provide functionality for review, analysis, and reporting of cardiac ultrasound data.

  • What versions of the EchoPAC Software Only are currently available?

    The EchoPAC Software Only is available in multiple versions, including v202.74.0. These versions are designed to offer updated features and compatibility with evolving clinical workflows and imaging standards. GE HealthCare provides support and updates for these versions.

  • How is the sterility and single-use or reuse status of the EchoPAC Software Only determined?

    The EchoPAC Software Only is a software-based solution and does not involve physical materials that require sterility or single-use considerations. Since it operates digitally, it is intended for repeated use within a clinical setting, provided it is maintained and updated according to manufacturer guidelines.

  • What regulatory pathway does the EchoPAC Software Only follow, and what does this mean for clinicians?

    The EchoPAC Software Only has received FDA 510(k) authorization, which means it has been deemed substantially equivalent to a legally marketed predicate device. This regulatory clearance ensures that the software meets established safety and effectiveness standards for use in clinical cardiac imaging reviews and diagnostics.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K200852-1 24 fields · synced 22 Oct 2026