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
10
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 10 devices under product code QJU between 2020 and 2026, filed by 8 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.