Cleared Traditional

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert

K213642 · Ge Healthcare · Radiology
Jan 2022
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K213642 is an FDA 510(k) clearance for the Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert, 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 January 13, 2022, 56 days after receiving the submission on November 18, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K213642 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2021
Decision Date January 13, 2022
Days to Decision 56 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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