Home / 510(k) Clearances / K251416

510(k) K251416

UltraSight Guidance by Ultrasight , Ltd. — Product Code QJU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2025
Date Received
May 7, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Device Class
Class II
Regulation Number
892.2100
Review Panel
RA
Submission Type

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.

Other clearances by Ultrasight , Ltd.

  • K252235 — PVAD IQ Software (December 18, 2025)
  • K223347 — UltraSight AI Guidance (July 24, 2023)

Other clearances for product code QJU

  • K242807 — HeartFocus (V.1.1.1) (April 4, 2025)
  • K243065 — Cardiac Guidance (January 15, 2025)
  • K223347 — UltraSight AI Guidance (July 24, 2023)
  • K201992 — Caption Guidance (September 18, 2020)
  • K200755 — Caption Guidance (April 16, 2020)
  • DEN190040 — Caption Guidance (February 7, 2020)