Cleared Traditional

Vivid T9/Vivid T8

K243628 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Radiology
Feb 2025
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K243628 is an FDA 510(k) clearance for the Vivid T9/Vivid T8, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics (Waukesha, US). The FDA issued a Cleared decision on February 11, 2025, 78 days after receiving the submission on November 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K243628 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2024
Decision Date February 11, 2025
Days to Decision 78 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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