FDA-cleared K251351

AccuContour 4.0

Manteia Technologies Co., Ltd.

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...

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.

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

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.

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...

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.

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

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