Cleared Special

GE VOLUSON E8 ULTRASOUND SYSTEM

K061682 · General Electric Co. · Radiology
Jul 2006
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K061682 is an FDA 510(k) clearance for the GE VOLUSON E8 ULTRASOUND SYSTEM, 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 July 12, 2006, 27 days after receiving the submission on June 15, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K061682 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2006
Decision Date July 12, 2006
Days to Decision 27 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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