Cleared Traditional

Voluson E10

K201768 · Ge Healthcare · Radiology
Oct 2020
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K201768 is an FDA 510(k) clearance for the 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 October 22, 2020, 115 days after receiving the submission on June 29, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K201768 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2020
Decision Date October 22, 2020
Days to Decision 115 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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