Cleared Special

GE LOGIQ TWIN

K050126 · General Electric Co. · Radiology
Feb 2005
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K050126 is an FDA 510(k) clearance for the GE LOGIQ TWIN, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by General Electric Co. (Milwaukee, US). The FDA issued a Cleared decision on February 2, 2005, 14 days after receiving the submission on January 19, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K050126 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2005
Decision Date February 02, 2005
Days to Decision 14 days
Submission Type Special
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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