Image Acquisition And/or Optimization Guided By Artificial Intelligence

Product Code: QJU

Radiology Diagnostic Ultrasound Devices

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.

Applicable Standards: None

Code of Federal Regulations: 892.2100

• Radiation Type: Acoustic
• Radition Safety: None
• Annual Reports: No

Pre-market Notifications for QJU

K201992	Caption Guidance	Caption Health
K200755	Caption Guidance	Caption Health

Global Unique Device Identification Database

• 00860003586303: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
• 00860003586310: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
• 00860003586334: Image Acquisition And/Or Optimization Guided By Artificial Intelligence
• 00860003586341: Image Acquisition And/Or Optimization Guided By Artificial Intelligence