Cleared Traditional

Sonosite LX Ultrasound System

K251830 · FUJIFILM Sonosite, Inc. · Radiology
Jul 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K251830 is an FDA 510(k) clearance for the Sonosite LX Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by FUJIFILM Sonosite, Inc. (Bothell, US). The FDA issued a Cleared decision on July 10, 2025, 27 days after receiving the submission on June 13, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K251830 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2025
Decision Date July 10, 2025
Days to Decision 27 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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