Cleared Traditional

Voluson Signature 20, Voluson Signature 18

K233692 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Mar 2024
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K233692 is an FDA 510(k) clearance for the Voluson Signature 20, Voluson Signature 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 March 7, 2024, 111 days after receiving the submission on November 17, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K233692 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2023
Decision Date March 07, 2024
Days to Decision 111 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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