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FDA-cleared K173420

Radiomics App v1.0

Microsoft Corp.

Authorized purpose: Microsoft Radiomics App v1.0 is a software-only medical device for trained radiation oncologists, dosimetrists, and physicists to derive organ and tumor contours for radiation-treatment planning. It supports CT and MR images, image and contour review, contour creation and modification, transfer to treatment-planning systems, adaptive-therapy support, archiving, tumor and healthy-structure localization, image fusion, and three-dimensional rendering. Images reviewed with the software should not be used for primary image interpretations, and it is not for digital mammography.

Modality
Radiotherapy Planning Imaging
Anatomy
CT and MR images; tumors and healthy anatomical structures for radiotherapy planning
Decision
2017-12-27