Contour ProtegeAI
K193252MIM Software Inc. · cleared 2020-07-02 · product code QKB · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Contour ProtégéAI is an accessory to MIM software used for the contouring of anatomical structures in imaging data using machine-learning-based algorithms automatically.”
source quote (p.3)
“The creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management. The neural networks used in the Contour ProtégéAI device were trained on datasets from several large institutions.”
Validation studies (1)
Retrospective clinical
n=286 images
endpoints: non-inferiority of mean Dice coefficient
Reported performance (1 observation)
source quote (p.11)
“This non-inferiority test compared the mean Dice coefficient of the automatically generated contours for Contour ProtégéAI against that of the predicate device. For all neural network models, evidence was established that the Contour ProtégéAI device was non-inferior to the predicate by at least a non-inferiority limit of 0.1 Dice, which was as the largest difference that is clinically acceptable based on previous studies, and thus we conclude that equivalence has been demonstrated.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K210632 (decision 2021-10-20) from MIM Software Inc. for a matching device line ("Contour ProtegeAI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K210632
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).