Cleared Traditional

Sonosite LX Ultrasound System

K233597 · FUJIFILM Sonosite, Inc. · Radiology
Dec 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K233597 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 December 6, 2023, 28 days after receiving the submission on November 8, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K233597 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2023
Decision Date December 06, 2023
Days to Decision 28 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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