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 TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Pre-market Notifications for QJU

K201992Caption GuidanceCaption Health
K200755Caption GuidanceCaption Health

Global Unique Device Identification Database

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

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