Cleared Traditional

LOGIQ E10

K200158 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
Apr 2020
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K200158 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 & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on April 17, 2020, 86 days after receiving the submission on January 22, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K200158 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2020
Decision Date April 17, 2020
Days to Decision 86 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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