Contour ProtégéAI+
K253270Mim Software, Inc. · cleared 2026-03-27 · 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.”
AlgorithmMultiple 3D U-Net models are trained, with each tailored to a specific anatomical structure or groups of structures (complexes) within a model bundle.
source quote (p.8)
“Multiple 3D U-Net models are trained, with each tailored to a specific anatomical structure or groups of structures (complexes) within a model bundle.”
Adaptive (vs locked)FDA source did not state this
PCCPYes
source quote (p.2)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Retrospective clinical
n=189 images · 7 site(s)
endpoints: Dice score; Mean Distance to Agreement (MDA); Added Path Length (APL); User evaluation score
standards: ISO 13485
Reported performance (2 observations)
diceas written: “Brain MR Brain Dice”0.97
source quote (p.14)
“0.97 ± 0.01”
diceas written: “Bladder CT Male Pelvis Dice”0.91
source quote (p.15)
“0.91 ± 0.12”
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
0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
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).