Radiology

UltraSight Guidance

Ultrasight , Ltd.

FDA-cleared AI medical device

A radiological acquisition and/or optimization guidance system is a device that is intended to aid in the acquisition and/or optimization of images and/or diagnostic signals. The device interfaces with the acquisition system, analyzes its output, and provides guidance and/or feedback to the operator for improving image and/or signal quality.

FDA Submission Metadata

Submission number
K251416
Decision date
December 2025
FDA panel
Radiology
Product code
QJU

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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