Cleared Traditional

LOGIQ E10

K231966 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Nov 2023
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K231966 is an FDA 510(k) clearance for the LOGIQ E10, 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 November 7, 2023, 127 days after receiving the submission on July 3, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K231966 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2023
Decision Date November 07, 2023
Days to Decision 127 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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