Cleared Special

GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

K072797 · General Electric Co. · Radiology
Oct 2007
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K072797 is an FDA 510(k) clearance for the GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by General Electric Co. (Wauwatosa, US). The FDA issued a Cleared decision on October 17, 2007, 16 days after receiving the submission on October 1, 2007. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K072797 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2007
Decision Date October 17, 2007
Days to Decision 16 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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