Contour ProtégéAI+

K250035

MIM Software Inc. · cleared 2025-02-03 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Contour ProtégéAI+ is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems.”

Algorithmmachine-learning algorithms and neural network model

source quote (p.6)

“Contour ProtégéAI+ is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. In the upcoming 1.4.0 release, one new neural network model is being added and three existing neural network models are being updated by retraining with additional or updated contours which prompted this premarket submission of the subject device.”

Adaptive (vs locked)No

source quote (p.7)

“In the upcoming 1.4.0 release, one new neural network model is being added and three existing neural network models are being updated by retraining with additional or updated contours which prompted this premarket submission of the subject device.”

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=770 images · 32 site(s)

endpoints: Dice score; MDA; time savings; cumulative Added Path Length (APL); localization accuracy; user evaluation

Reported performance (2 observations)

diceas written: “Dice score”0.41CI 0.41 ± 0.15 (0.28)

source quote (p.13)

“0.41 ± 0.15 (0.28) *”

accuracyas written: “Localization Accuracy (Relevant FOV)”100

source quote (p.18)

“100”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K253270 (decision 2026-03-27) from Mim Software, Inc. for a matching device line ("Contour ProtégéAI+") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.
first seen 2026-07-08 · k_number:K253270

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).