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Versana Premier; Versana Premier Lotus; LOGIQ F

by GE Medical Systems Ultrasound and Primary Care Diagnostics

510(k) K242005

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 NumberK242005 Date2 Oct 2024ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2030-2025 FDA Class II initiated 16 May 2025
    • Ongoing Z-2029-2025 FDA Class II initiated 16 May 2025

    GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.

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  • Withdrawn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, 27 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 Versana Premier ultrasound system is designed for general practice clinics, offering advanced imaging qualities across a wide range of clinical areas. It is equipped with automation features and intuitive controls to enhance efficiency and provide optimal care.

This system is supplied for use in various settings including imaging centers, multi-purpose clinics, family doctor's offices, and hospitals. It is authorized under FDA 510K clearance with product code IYN and is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

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

AI-generated answers, 27 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 Versana Premier ultrasound system designed for?

    The Versana Premier ultrasound system is designed for general practice clinics, offering advanced imaging qualities across a wide range of clinical areas. It features automation and intuitive controls to enhance efficiency and provide optimal care in various settings including imaging centers, multi-purpose clinics, family doctor's offices, and hospitals.

  • How is the Versana Premier ultrasound system supplied?

    The Versana Premier ultrasound system is supplied as a complete ultrasound imaging system for clinical use. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics and is available in multiple models including Versana Premier, Versana Premier Lotus, and LOGIQ F to meet different clinical needs.

  • What is the regulatory status of the Versana Premier ultrasound system?

    The Versana Premier ultrasound system is authorized under FDA 510K clearance with product code IYN. It received FDA clearance on October 2, 2024, after being submitted on July 9, 2024, with K number K242005. The system is classified under the traditional clearance pathway and reviewed by the Radiology Advisory Committee.

  • What features make the Versana Premier ultrasound system suitable for general practice?

    The Versana Premier ultrasound system offers advanced imaging qualities combined with automation features and intuitive controls specifically designed to enhance efficiency in general practice settings. These features help clinicians provide optimal care across a wide range of clinical applications while maintaining ease of use in various healthcare environments.