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 Caption Health, Inc..
10
Total
9
Cleared
148d
Avg days
2020
Since
Growing category -
6 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
161d
recently vs 129d historically
FDA 510(k) Cleared Image Acquisition And/or Optimization Guided By Artificial Intelligence Devices (Product Code QJU)
10 devices
Cleared
Oct 02, 2026
Lung Guidance
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology
185d
Cleared
Jul 15, 2026
ThinkSono Guidance
ThinkSono GmbH
Radiology
163d
Cleared
Jun 03, 2026
HeartFocus
Deski
Radiology
85d
Cleared
Dec 17, 2025
UltraSight Guidance
Ultrasight , Ltd.
Radiology
224d
Cleared
Apr 04, 2025
HeartFocus (V.1.1.1)
Deski
Radiology
199d
Cleared
Jan 15, 2025
Cardiac Guidance
Caption Health, Inc.
Radiology
110d
Cleared
Jul 24, 2023
UltraSight AI Guidance
Ultrasight, Inc.
Radiology
265d
Cleared
Sep 18, 2020
Caption Guidance
Caption Health
Radiology
63d
Cleared
Apr 16, 2020
Caption Guidance
Caption Health
Radiology
24d
Not Cleared
Feb 07, 2020
Caption Guidance
Bay Labs, Inc.
Radiology
164d
About Product Code QJU - Regulatory Context
510(k) Submission Activity
10 total 510(k) submissions under product code QJU since 2020, with 9 receiving FDA clearance (average review time: 148 days).
Submission volume has increased in recent years - 6 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 161 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 →