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LOGIQ E10s, LOGIQ Fortis

by Ge Medical Systems Ultrasound and Primary Care Diagnostic,

510(k) K231989

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 NumberK231989 Date7 Nov 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  • Withdrawn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
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 Logiq E10s and Logiq Fortis are ultrasound systems designed for general imaging. These devices provide imaging capabilities to assist clinicians in scanning, diagnosing, and treating a wide range of patients across a broad spectrum of conditions.

These systems feature artificial intelligence-based decision support and workflow solutions to enhance productivity. The devices are authorized under FDA 510k clearance, identified by k-number K231989.

Other devices from Ge Medical Systems Ultrasound and Primary Care Diagnostic,

  • LOGIQ e

    Class II

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 are the LOGIQ E10s and LOGIQ Fortis systems used for?

    These ultrasound systems are designed for general imaging applications. They provide clinicians with the necessary imaging capabilities to assist in the scanning, diagnosis, and treatment of a wide range of patients across a broad spectrum of medical conditions.

  • Do these ultrasound systems include automated features?

    Yes, both the LOGIQ E10s and LOGIQ Fortis incorporate artificial intelligence-based decision support and workflow solutions. These features are integrated into the systems to help enhance clinical productivity during diagnostic procedures.

  • What is the regulatory status of these devices?

    The LOGIQ E10s and LOGIQ Fortis systems are authorized under FDA 510k clearance, identified by k-number K231989. The submission was processed as a traditional 510k, resulting in a determination of substantial equivalence.