Cleared Traditional

LOGIQ Fortis

K253366 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Jan 2026
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K253366 is an FDA 510(k) clearance for the LOGIQ Fortis, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on January 7, 2026, 99 days after receiving the submission on September 30, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K253366 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2025
Decision Date January 07, 2026
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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