Cleared Traditional

Vivid iq

K221148 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · Radiology
Jul 2022
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K221148 is an FDA 510(k) clearance for the Vivid iq, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (Wauwatosa, US). The FDA issued a Cleared decision on July 18, 2022, 89 days after receiving the submission on April 20, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K221148 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2022
Decision Date July 18, 2022
Days to Decision 89 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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