QJU

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Product code
QJU
Device name
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Device class
Class 2
21 CFR
21 CFR 892.2100
Medical specialty
Radiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
5
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-07-15.

NumberDecision dateApplicantDevice nameSummary
K2603382026-07-15ThinkSono GmbHThinkSono GuidancePDF
K2607802026-06-03DeskiHeartFocusPDF
K2514162025-12-17Ultrasight , Ltd.UltraSight GuidancePDF
K2428072025-04-04DeskiHeartFocus (V.1.1.1)FDA
K2430652025-01-15Caption Health, Inc.Cardiac GuidanceFDA

3 summaries are archived here for direct download.

Official FDA classification page: QJU
Classification and pathway per current FDA publications. Data from openFDA (CC0).