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FDA-cleared K231855

QOCA® image Smart RT Contouring System

Quanta Computer Inc.

Authorized purpose: QOCA image Smart RT Contouring System automatically contours DICOM CT imaging data using deep-learning algorithms. Generated contours may be used as input to external-beam radiation-therapy planning and are output as RTSTRUCT objects for radiation-oncology departments.

Modality
Radiotherapy Planning Imaging
Anatomy
Adult patient anatomy represented in CT images and radiation-treatment structures
Decision
2024-02-13
FDA-cleared K221868

QOCA image Smart CXR Image Processing System

Quanta Computer Inc.

Authorized purpose: QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-01-27