510(k) · Radiology

Sonosite LX and Sonosite PX Ultrasound Systems

by Fujifilm Sonosite Inc

Sonosite LX and Sonosite PX Ultrasound Systems is an AI-enabled medical device from Fujifilm Sonosite Inc that the U.S. FDA cleared through 510(k) K251106 on August 29, 2025. Its lead review panel is Radiology and its primary product code is IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK251106
Pathway510(k)
Date of final decision
Company (FDA list)Fujifilm Sonosite Inc
Lead review panelRadiology
Primary product codeIYN — System, Imaging, Pulsed Doppler, Ultrasonic
Applicant (openFDA)FUJIFILM Sonosite, Inc.
Applicant locationBothell, WA, US
Device classClass 2
Regulation number21 CFR 892.1550
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Sonosite LX and Sonosite PX Ultrasound Systems went through this pathway (K251106).

openFDA lists it as a Class 2 device under 21 CFR 892.1550. Class II devices are moderate risk and are subject to general and special controls.

Product code IYN covers 124 devices on the FDA AI list. By decision date, this device is #100 of 124 under that code. Fujifilm Sonosite Inc has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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