Contour ProtegeAI

K210632

MIM Software Inc. · cleared 2021-10-20 · product code QKB · Radiology

FDA 510(k) summary for Contour ProtegeAI (K210632)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
1
Product code
QKB
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Contour ProtégéAI is an accessory to MIM software. It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically.”
Algorithmmachine-learning-based algorithms, neural network models
source quote (p.4)
“It includes processing components to allow the contouring of anatomical structures using machine-learning-based algorithms automatically. new and modified CT neural network models with additional contours, a modified Prostate MR neural network model”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: Dice coefficient

Reported performance (1 observation)

diceas written: “Dice coefficient”stated without valueCI lower 95th percentile confidence bound
source quote (p.10)
“The mean and standard deviation Dice coefficients, along with the lower 95th percentile confidence bound, were calculated for both the proposed Contour ProtégéAI device and the MIM Maestro atlas segmentation reference device for each structure of each neural network model. Contour ProtégéAI results were equivalent or had better performance than the MIM atlas segmentation reference device. Equivalence is defined such that the lower 95th percentile confidence bound of the Contour ProtégéAI segmentation is greater than 0.1 Dice lower than the mean MIM Maestro atlas segmentation reference device performance.”

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
2
drift signals on this device
  • predicate_cohort_contagion

    K210632 shares predicate K071964 with K173444 (Quantitative Total Extensible Imaging (QTxI)), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K071964 sibling:K173444

  • predicate_cohort_contagion

    K210632 shares predicate K071964 with K233998 (TRAQinform IQ), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K071964 sibling:K233998

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-08-26.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code QKB

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Contour ProtégéAI+

K253270

Mim Software, Inc.

cleared 2026-03-27

AutoContour (RADAC V5)

K260509

Radformation, Inc.

cleared 2026-03-19

Seg Pro V3 (RT-300)

K251306

Ever Fortune.Ai, Co., Ltd.

cleared 2026-01-28

AccuContour 4.0

K251351

Manteia Technologies Co., Ltd.

cleared 2026-01-23

ARTAssistant

K250780

Manteia Technologies Co., Ltd.

cleared 2025-12-05

TAIMedImg DeepMets

K250427

Taiwan Medical Imaging Co., Ltd.

cleared 2025-05-28

MR Contour DL

K242925

GE HealthCare

cleared 2025-04-01

AI-Rad Companion Organs RT

K242745

Siemens Healthcare GmbH

cleared 2025-03-27

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K210632