DeviceClearance

Product code QJU— Radiology

Caption Guidance

Classification name
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Device class
Class 2
Regulation
21 CFR 892.2100
Advisory panel
Radiology
Total cleared
9
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QJU under 21 CFR 892.2100, via openFDA

Market context for product code QJU

FDA has cleared 9 devices under product code QJU between 2020 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QJU

Recent clearances under product code QJU

Data sourced from openFDA. This site is unofficial and independent of the FDA.