510(k) · Radiology

UltraSight Guidance

by Ultrasight , Ltd.

UltraSight Guidance is an AI-enabled medical device from Ultrasight , Ltd. that the U.S. FDA cleared through 510(k) K251416 on December 17, 2025. Its lead review panel is Radiology and its primary product code is QJU (Image Acquisition And/Or Optimization Guided By Artificial Intelligence).

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

Key facts

Submission numberK251416
Pathway510(k)
Date of final decision
Company (FDA list)Ultrasight , Ltd.
Lead review panelRadiology
Primary product codeQJU — Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Applicant (openFDA)Ultrasight , Ltd.
Applicant locationNess Ziona, IL
Device classClass 2
Regulation number21 CFR 892.2100
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. UltraSight Guidance went through this pathway (K251416).

openFDA lists it as a Class 2 device under 21 CFR 892.2100. Class II devices are moderate risk and are subject to general and special controls.

Product code QJU covers 8 devices on the FDA AI list. By decision date, this device is #7 of 8 under that code. Ultrasight , Ltd. has 2 AI-enabled devices 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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