QJUClass II

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

21 CFR 892.2100 / Radiology

QJU is the FDA product code for Image Acquisition And/Or Optimization Guided By Artificial Intelligence, a class II device type, regulated under 21 CFR 892.2100. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2026-07-15, and no recalls.

Classification record

Product code: QJU
Device name: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
FDA 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.
Regulation: 21 CFR 892.2100
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 0

Clearances, product code QJU

By decision year

9 clearances under product code QJU with a decision year between 2020 and 2026, 2020 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code QJU by decision year
Year	Clearances
2020	3
2023	1
2025	3
2026	2

Applicants with the most clearances

Product code QJU

Applicants holding the most 510(k) clearances under product code QJU
Applicant	Clearances
Caption Health	3
Deski	2
Ultrasight	2
Bay Labs, Inc.	1
Thinksono GmbH	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QJU

Recent recalls

Product code QJU

FDA records show no recalls under product code QJU.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)