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FDA-cleared K251351

AccuContour 4.0

Manteia Technologies Co., Ltd.

Authorized purpose: AccuContour 4.0 uses deep-learning contours to support segmentation of organs at risk on CT images for radiation-treatment planning, evaluation, and adaptation; qualified professionals review and may edit the contours.

Modality
Radiotherapy Planning Imaging
Anatomy
Head and neck, thorax, abdomen, and pelvis organs at risk
Decision
2026-01-23
FDA-cleared K250780

ARTAssistant

Manteia Technologies Co., Ltd.

Authorized purpose: ARTAssistant supports image registration and synthetic CT generation for adaptive radiation-treatment planning, evaluation, and adaptation from labeled MRI and treatment-planning inputs.

Modality
Radiotherapy Planning Imaging
Anatomy
Head, neck, brain, body, and radiation-treatment structures
Decision
2025-12-05
FDA-cleared K223724

MOZI TPS

Manteia Technologies Co., Ltd.

Authorized purpose: The MOZI Treatment Planning System is used to plan radiotherapy treatments for patients with malignant or benign diseases and is used to plan external-beam irradiation with photon beams.

Modality
Radiotherapy Planning Imaging
Anatomy
Patient anatomy represented in external-beam photon-treatment plans
Decision
2023-07-10
FDA-cleared K221706

AccuContour

Manteia Technologies Co., Ltd.

Authorized purpose: AccuContour generates and supports editing of organ-at-risk contours from multimodality imaging, including noncontrast CT, for radiation-treatment planning, evaluation, and adaptation.

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-03-09