Cleared Special

GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04

K041688 · General Electric Co. · Radiology
Jul 2004
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K041688 is an FDA 510(k) clearance for the GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04, 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 8, 2004, 16 days after receiving the submission on June 22, 2004. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K041688 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2004
Decision Date July 08, 2004
Days to Decision 16 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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