Cleared Traditional

LOGIQ E10

K211488 · Ge Healthcare · Radiology
Sep 2021
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K211488 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 Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on September 10, 2021, 120 days after receiving the submission on May 13, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K211488 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2021
Decision Date September 10, 2021
Days to Decision 120 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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