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Vivid S60N, Vivid S70N

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

Active United States

510(k) K182450

Overview

The device is an ultrasound system designed for diagnostic imaging. It is intended for use in radiology and primary care diagnostics settings.

The system is supplied as a non-sterile, reusable device. It has received FDA 510(k) clearance under K182450 with product code IYN and is classified as substantially equivalent to a predicate device.

AI-generated from registry data, 26 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

Recall ongoing. 2 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182450 Date19 Oct 2018ClearedStatusActive

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 AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

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.

Specification

510(k)

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

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Questions

  • What is the Vivid S60N and Vivid S70N ultrasound system used for?

    The Vivid S60N and Vivid S70N ultrasound systems are designed for diagnostic imaging and are intended for use in radiology and primary care diagnostics settings, as stated in the device description.

  • Is the Vivid S60N and Vivid S70N ultrasound system sterile or non-sterile, and is it for single use or reuse?

    The device is supplied as a non-sterile, reusable system, meaning it is not provided in a sterile condition and is designed for multiple uses after appropriate cleaning and disinfection between patients.

  • What regulatory pathway was used for the Vivid S60N and Vivid S70N ultrasound system?

    The Vivid S60N and Vivid S70N received FDA 510(k) clearance under submission K182450, with a determination of substantial equivalence to a predicate device, as indicated in the device data.