Cleared Traditional

Sonosite MT Ultrasound System

K253448 · FUJIFILM Sonosite, Inc. · Radiology
Nov 2025
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K253448 is an FDA 510(k) clearance for the Sonosite MT 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 November 3, 2025, 32 days after receiving the submission on October 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K253448 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2025
Decision Date November 03, 2025
Days to Decision 32 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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