FDA-cleared K253270

Contour ProtégéAI+

Mim Software, Inc.

Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2026-03-27
FDA-cleared K250035

Contour ProtégéAI+

MIM Software Inc.

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;...

Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomical regions; prostate, seminal vesicles, and urethra on T2 MR
Decision
2025-02-03
FDA-cleared K231765

Contour ProtégéAI

MIM Software Inc.

Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, creates machine-learning contours for quantitative analysis, adaptive...

Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
Decision
2023-11-08
FDA-cleared K223774

Contour ProtégéAI

MIM Software Inc.

Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, machine-learning contour creation for quantitative analysis, adaptive...

Modality
Radiotherapy Planning Imaging
Anatomy
CT anatomic locations and the prostate, seminal vesicles, and urethra on T2-weighted MR
Decision
2023-04-06
FDA-cleared K213976

Contour ProtégéAI

MIM Software Inc.

Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
Decision
2022-02-03
FDA-cleared K210632

Contour ProtegeAI

MIM Software Inc.

Contour ProtegeAI creates initial contours from supported radiotherapy images to support treatment planning and related analysis; qualified radiation professionals must review,...

Modality
Radiotherapy Planning Imaging
Anatomy
Head, neck, thorax, abdomen, pelvis, and other labeled radiotherapy structures
Decision
2021-10-20
FDA-cleared K193252

Contour ProtegeAI

MIM Software Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Normal structures in CT anatomy; prostate, seminal vesicles, and urethra on T2-weighted MR
Decision
2020-07-02