Contour ProtégéAI

K223774

MIM Software Inc. · cleared 2023-04-06 · product code QKB · Radiology

FDA 510(k) summary for Contour ProtégéAI (K223774)

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.5)
“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. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.”
Algorithmmachine-learning algorithms / neural network models
source quote (p.4)
“Contour ProtégéAI is an accessory to MIM software. It includes processing components to automatically contour imaging data using machine-learning based algorithms. ... Changes within this submission include new 4.0.0 CT neural network models with additional contours.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=819 images · 10 site(s)

endpoints: Dice score

Reported performance (1 observation)

diceas written: “Dice coefficient (Bone_Mandible)”0.85CI 0.82
source quote (p.13)
“Head and Neck Bone_Mandible 0.81 ± 0.07 0.85 ± 0.07 (0.82) *”

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
6
drift signals on this device
  • predicate_cohort_contagion

    K223774 shares predicate K213976 with K243762 (Synapse 3D Base Tools (V7.0)), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K213976 sibling:K243762

  • predicate_cohort_contagion

    K223774 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

    K223774 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

  • 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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231765 (decision 2023-11-08) 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:K231765

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/K223774