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Voluson SWIFT; Voluson SWIFT+

by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC

510(k) K230346

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK230346 Date20 Jun 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Voluson SWIFT and Voluson SWIFT+ are ultrasound systems designed for women's health applications. These systems are cart-based and feature 3D/4D imaging capabilities, with a large touchscreen interface and built-in battery for portability. They include HDlive and Radiantflow imaging technologies to enhance diagnostic capabilities.

The Voluson SWIFT systems are supplied as cart-based units and are intended for use in clinical settings. They have received FDA 510(k) clearance with the product code IYN and are substantially equivalent to predicate devices. The systems are designed to simplify the OB/GYN scanning process and integrate seamlessly into women's health practices.

Questions

AI-generated answers, 24 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 is the Voluson SWIFT+ ultrasound system designed for?

    The Voluson SWIFT+ is a cart-based ultrasound system specifically designed for women's health applications, featuring 3D/4D imaging capabilities and technologies like HDlive and Radiantflow to enhance diagnostic capabilities in OB/GYN settings.

  • How is the Voluson SWIFT system supplied and what are its key features?

    The Voluson SWIFT systems are supplied as complete cart-based units with a large touchscreen interface and built-in battery for portability. They are designed to simplify OB/GYN scanning processes and integrate seamlessly into women's health practices.

  • What regulatory status does the Voluson SWIFT system have?

    The Voluson SWIFT systems have received FDA 510(k) clearance with product code IYN and are classified as substantially equivalent to predicate devices, filed under the traditional clearance type with the Radiology advisory committee.

  • Can the Voluson SWIFT system be used in different clinical settings?

    Yes, the Voluson SWIFT systems are intended for use in clinical settings, particularly those focused on women's health. Their cart-based design with battery operation allows for flexibility in various clinical environments while maintaining the advanced imaging capabilities needed for OB/GYN diagnostics.