Cleared Traditional

LOGIQ Totus

K232381 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Dec 2023
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K232381 is an FDA 510(k) clearance for the LOGIQ Totus, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Wauwatosa, US). The FDA issued a Cleared decision on December 7, 2023, 121 days after receiving the submission on August 8, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K232381 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2023
Decision Date December 07, 2023
Days to Decision 121 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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