QJU · Class II · 21 CFR 892.2100

FDA Product Code QJU: Image Acquisition And/or Optimization Guided By Artificial Intelligence

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.

Leading manufacturers include Caption Health, Deski and Ultrasight, Inc..

Total

Cleared

142d

Avg days

2020

Since

Growing category - 4 submissions in the last 2 years vs 1 in the prior period

Review times increasing: avg 155d recently vs 129d historically

FDA 510(k) Cleared Image Acquisition And/or Optimization Guided By Artificial Intelligence Devices (Product Code QJU)

8 devices

1–8 of 8

UltraSight AI Guidance

Not Cleared Feb 07, 2020

About Product Code QJU - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code QJU since 2020, with 7 receiving FDA clearance (average review time: 142 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QJU Product Code

Recent submissions under QJU have taken an average of 155 days to reach a decision - up from 129 days historically. Manufacturers should account for longer review timelines in current project planning.

QJU devices are reviewed by the Radiology panel. Browse all Radiology devices →

Related FDA 510(k) Regulatory Insights

Data Source

FDA 510(k) public files . 175,450 total devices indexed.

Latest clearance: Jun 03, 2026

Product Code Info

Code	QJU
Device class	Class II
CFR	21 CFR 892.2100
Panel	Radiology

Top Image Acquisition And/or Optimization Guided By Artificial Intelligence Manufacturers

Verify on FDA.gov

View QJU classification on FDA.gov →