Cleared Special

GE VIVID - I

K061525 · General Electric Co. · Radiology
Jul 2006
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K061525 is an FDA 510(k) clearance for the GE VIVID - I, 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 July 3, 2006, 31 days after receiving the submission on June 2, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K061525 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2006
Decision Date July 03, 2006
Days to Decision 31 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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