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Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?
Authorized purpose: Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and archiving subject to qualified review and editing.
Modality
Radiological images; modality varies or is not specified in FDA list
Authorized purpose: Contour ProtégéAI+ automatically creates contours on CT and T2 MR DICOM images as an accessory to MIM software for quantitative analysis, adaptive therapy, transfer, and archive; users must review and edit contours, and the device is not intended to detect or contour lesions.
Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomical regions; prostate, seminal vesicles, and urethra on T2 MR
Authorized purpose: Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, creates machine-learning contours for quantitative analysis, adaptive therapy, transfer to radiation-treatment planning systems, and archiving, segments structures across CT locations, and segments the prostate, seminal vesicles, and urethra on T2-weighted MR images.
Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
Authorized purpose: Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, machine-learning contour creation for quantitative analysis, adaptive therapy, transfer to radiation-treatment planning systems, and archiving, segmentation across CT locations, and segmentation of the prostate, seminal vesicles, and urethra on T2-weighted MR images.
Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
Authorized purpose: Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and follow-up; professionals must visualize, review, and edit contours, and the software is not intended to detect or contour lesions.
Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
Authorized purpose: Contour ProtegeAI creates initial contours from supported radiotherapy images to support treatment planning and related analysis; qualified radiation professionals must review, edit, and approve outputs for the exact labeled structures.
Modality
Radiotherapy Planning Imaging
Anatomy
Head, neck, thorax, abdomen, pelvis, and other labeled radiotherapy structures
Authorized purpose: Contour ProtegeAI is used by trained medical professionals as a tool for automated processing of CT and MR medical images. It creates contours with machine-learning algorithms for quantitative analysis, adaptive therapy support, transfer to radiation-treatment planning systems, and archiving, segments normal structures across CT anatomical locations, and segments the prostate, seminal vesicles, and urethra in T2-weighted MR images. It must be used with MIM software to review and, if necessary, edit automatically generated contours.
Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in CT anatomy; prostate, seminal vesicles, and urethra on T2-weighted MR