Cleared Traditional

Voluson E6, Voluson E8, Voluson E10

K192159 · Ge Healthcare · Radiology
Aug 2019
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K192159 is an FDA 510(k) clearance for the Voluson E6, Voluson E8, Voluson E10, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on August 29, 2019, 20 days after receiving the submission on August 9, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K192159 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2019
Decision Date August 29, 2019
Days to Decision 20 days
Submission Type Traditional
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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