Radiomics App v1.0
Microsoft Corp.Radiomics App v1.0 by Microsoft is a software tool designed to help trained radiation oncologists, dosimetrists, and physicists create precise three-dimensional contours of tumors and healthy anatomical structures in CT and MRI scans. This assists in radiation treatment planning by providing optimized organ and tumor segmentation, supporting improved treatment evaluation and planning workflows.
Intended Use
Software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to derive optimal organ and tumor contours for input to radiation treatment planning using CT and MRI images.
Technology
Software applying machine learning and image processing algorithms for assisted, automatic, and refinement contouring of tumors and anatomical structures on CT and MR images, integrated into clinical radiation therapy workflows.
Performance
Verification and validation testing demonstrated that the software meets user needs and performs according to specifications, supporting substantial equivalence to the predicate device. No clinical or animal studies were deemed necessary.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/1/2017
1 month - 2
FDA Approval
12/27/2017
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