Contour ProtégéAI

K231765

MIM Software Inc. · cleared 2023-11-08 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning based algorithms.”

Algorithmmachine-learning algorithms, neural network models

source quote (p.4)

“Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. A total of 550 CT images from 41 clinical sites across multiple continents was gathered for the training of the final 4.1.0 neural network models.”

Adaptive (vs locked)No

source quote (p.5)

“A total of 550 CT images from 41 clinical sites across multiple continents was gathered for the training of the final 4.1.0 neural network models.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=754 images · 27 site(s)

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

Reported performance (2 observations)

diceas written: “Dice Contour ProtégéAI - Bone_Mandible”0.86CI 0.83

source quote (p.13)

“0.86 ± 0.07 (0.83) *”

diceas written: “Dice Contour ProtégéAI - BrachialPlex_L”0.22CI 0.14

source quote (p.13)

“0.22 ± 0.10 (0.14) *”

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
re_clearance
The FDA AI/ML device list shows a newer 510(k) K250035 (decision 2025-02-03) from MIM Software Inc. for a matching device line ("Contour ProtégéAI+") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250035

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).