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Vivid S60N, Vivid S70N

by Ge Medical System Ultrasound and Primary Care Diagnostics

510(k) K223832

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223832 Date16 Feb 2023ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2127-2023 FDA Class II initiated 30 May 2023
    • Ongoing Z-2126-2023 FDA Class II initiated 30 May 2023

    GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Vivid S60N and Vivid S70N are portable ultrasound systems designed for advanced cardiac and general imaging. These devices provide high-resolution imaging, automated measurements, and enhanced visualization tools to support precise diagnostic assessments of cardiac function, valve dynamics, and other soft-tissue structures.

The systems are intended for use in clinical settings such as radiology departments and cardiac care units. Supplied sterile or non-sterile as specified by the facility, they may be reusable or single-use depending on institutional protocols. Both models comply with FDA 510(k) clearance under the Radiology Advisory Committee and are classified under product code IYN. Storage and handling follow standard ultrasound system guidelines to maintain performance and safety.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the primary clinical applications for the Vivid S60N and Vivid S70N ultrasound systems, and how do they support diagnostic assessments?

    The Vivid S60N and Vivid S70N are specifically designed for advanced cardiac and general imaging. They offer high-resolution imaging, automated measurements, and enhanced visualization tools to help clinicians assess cardiac function, valve dynamics, and soft-tissue structures with precision. These features make them particularly useful in radiology departments and cardiac care units for detailed diagnostic evaluations.

  • Are the Vivid S60N and Vivid S70N systems intended for sterile use, and how should they be handled in a clinical setting?

    The Vivid S60N and Vivid S70N systems are not inherently sterile or non-sterile by design—they can be used in either configuration based on facility protocols. Sterility or reuse depends on institutional policies, as these systems are versatile enough to accommodate both single-use and reusable workflows in clinical settings like radiology or cardiac care units.

  • What regulatory pathway did the Vivid S60N and Vivid S70N follow to gain market authorization, and which committee reviewed their submission?

    The Vivid S60N and Vivid S70N received FDA clearance through a 510(k) submission, classified as *Substantially Equivalent* under the Radiology Advisory Committee (RA). The submission was reviewed under product code IYN, and the decision was made by the Radiology (RA) Review Panel in February 2023.

  • How do the Vivid S60N and Vivid S70N differ in terms of their intended clinical environments or workflows?

    While both models are portable ultrasound systems for cardiac and general imaging, their primary distinction lies in their advanced imaging capabilities—such as high-resolution visualization and automated measurements—which are optimized for clinical settings like radiology departments and cardiac care units. The choice between the S60N and S70N would depend on specific institutional needs for imaging performance rather than a fundamental difference in intended use.