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 Ultrasight, Inc., Deski and Caption Health, Inc..
FDA 510(k) Cleared Image Acquisition And/or Optimization Guided By Artificial Intelligence Devices (Product Code QJU)
About Product Code QJU - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QJU since 2020, with 6 receiving FDA clearance (average review time: 150 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QJU have taken an average of 178 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 →