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ViewPoint 6

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

510(k) K203677

Product code LLZ

Overview

ViewPoint 6 is an ultrasound reporting and documentation software system designed for medical imaging departments and practices. It facilitates the management of ultrasound images and reports, helping to streamline workflow and improve efficiency in radiology settings.

The system is supplied by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC and has received FDA 510(k) clearance as substantially equivalent. It is designed to integrate with existing ultrasound systems and can help reduce transcription errors by channeling data directly into dictation systems.

Summary written by AI from registry data, 24 Sep 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

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK203677 Date15 Jan 2021ClearedStatusActive

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-3146-2024 FDA Class II initiated 8 Aug 2024

    The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.

Specification

510(k) · synced 22 Oct 2026

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

Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC

See all devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC →

Questions

  • What is the purpose of ViewPoint 6 ultrasound reporting software?

    ViewPoint 6 is designed to help medical imaging departments and practices manage ultrasound images and reports, streamlining workflow and improving efficiency in radiology settings by integrating with existing ultrasound systems and reducing transcription errors.

  • How is ViewPoint 6 supplied and what are its regulatory approvals?

    ViewPoint 6 is supplied by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC and has received FDA 510(k) clearance as substantially equivalent, with a decision date of January 15, 2021.

  • Can ViewPoint 6 integrate with existing ultrasound systems?

    Yes, ViewPoint 6 is designed to integrate with existing ultrasound systems, which helps reduce transcription errors by channeling data directly into dictation systems, improving overall workflow efficiency.

  • What is the product code and advisory committee for ViewPoint 6?

    ViewPoint 6 has a product code of LLZ and was reviewed by the Radiology Advisory Committee (RA), with a decision description of 'Substantially Equivalent' and a special clearance type.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K203677 24 fields · synced 22 Oct 2026