Cleared Traditional

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

K231965 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Oct 2023
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K231965 is an FDA 510(k) clearance for the Voluson Expert 22, Voluson Expert 20, Voluson Expert 18, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Wauwatosa, US). The FDA issued a Cleared decision on October 30, 2023, 119 days after receiving the submission on July 3, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K231965 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2023
Decision Date October 30, 2023
Days to Decision 119 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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