Cleared Special

GE VIVID 7 WITH OR WITHOUT SUFFIX

K051449 · GE Medical Systems · Radiology
Jun 2005
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K051449 is an FDA 510(k) clearance for the GE VIVID 7 WITH OR WITHOUT SUFFIX, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on June 16, 2005, 14 days after receiving the submission on June 2, 2005. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K051449 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2005
Decision Date June 16, 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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