Intended Use

Auto Positioning is intended for use with head, whole body, cardiac and vascular X-ray Computed Tomography applications.

Technology

The system uses a fixed ceiling-mounted 2D/3D video camera to acquire spatial information of the patient and CT gantry/table. It uses AI deep learning CNNs to automatically calculate scout scan start and end locations, check patient orientation, table height, and detect potential contact hazards. The software integrates with the CT system touchscreen and control workflow.

Performance

Performance was tested through software and system verification, validation, risk management, and bench testing. Testing showed that Auto Positioning meets design inputs, user needs, and applicable standards (including IEC60601-1 Ed 3.1). No unexpected results or new hazards were identified. Clinical testing was not required as functionality is a workflow enhancement.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/21/2019

    2 months
  • 2

    FDA Approval

    1/16/2020

Other devices from GE Hangwei Medical Systems, Co., Ltd.

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