Radiology AI Directory

FDA-cleared profile

Contour ProtégéAI

MIM Software Inc.

Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and follow-up; professionals must visualize, review, and edit contours, and the software is not intended to detect or contour lesions.

Radiotherapy planningProstate imagingDetection and CADeQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and follow-up; professionals must visualize, review, and edit contours, and the software is not intended to detect or contour lesions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified radiation oncologists, medical physicists, dosimetrists, and radiation therapists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Radiation-oncology departments using compatible planning, imaging, and treatment-delivery systems.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Radiotherapy contouring, treatment planning, adaptation, or treatment-session support under professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Supported CT or MR images, structures, prescriptions, plans, registrations, and treatment-session data.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Contours, treatment plans, adapted plans, dose or evaluation results, or session information requiring review and approval.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Generated contours require visualization, review, and editing; the exact labeled structures and CT or MR inputs determine applicability, and the software is not intended to detect or contour lesions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K213976
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiotherapy Planning Imaging
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Normal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-02-03
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
The exact FDA package describes MIMcloud remote-server and local workstation or server options for the Contour ProtégéAI release; verify the configured mode, data flow, security, and service boundary locally.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the release-level boundary described in the exact FDA package; current hosting, contracts, security, availability, and site configuration remain separate evidence.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified radiation oncologists, medical physicists, dosimetrists, and radiation therapists should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Monitoring and change control
Monitor K213976 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Generated contours require visualization, review, and editing; the exact labeled structures and CT or MR inputs determine applicability, and the software is not intended to detect or contour lesions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Monitoring guidance is buyer-facing implementation guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.

Release and scope verification

Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K213976 before acceptance.

exact submission · checked 2026-09-04

Later product-family features are not evidence that this cleared release includes them.

Source

Deployment boundary

The exact FDA package describes MIMcloud remote-server and local workstation or server options for the Contour ProtégéAI release; verify the configured mode, data flow, security, and service boundary locally.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

Source

Interoperability acceptance

The exact public integration contract remains incomplete; establish and test supported input, output, identity, routing, archive, and downtime behavior locally.

exact submission · checked 2026-09-04

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. Generated contours require visualization, review, and editing; the exact labeled structures and CT or MR inputs determine applicability, and the software is not intended to detect or contour lesions.

exact submission · checked 2026-09-04

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-04

No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.

Source

Lifecycle monitoring

Monitor K213976 by exact hardware, software, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: Generated contours require visualization, review, and editing; the exact labeled structures and CT or MR inputs determine applicability, and the software is not intended to detect or contour lesions.

exact submission · checked 2026-09-04

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes. radiotherapy planning or image-processing software limits remain submission-specific.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K213976 FDA decision material describes the cleared radiotherapy planning or image-processing software, labeled use, and submission-specific verification. It does not establish product-wide sensitivity, specificity, outcomes, or independent clinical validation for this exact configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not promoted as a product-wide endpoint for this device or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not promoted as a product-wide endpoint for this device or software function. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Production-model training dataset size

4061 CT images

  • EndpointImages used for final production models
  • PopulationCT images from 31 clinical sites
  • Tested versionContour ProtégéAI configuration described in K213976
Source

Production-model training site count

31 sites

  • EndpointClinical sites represented in final production-model training data
  • PopulationCT images used for final production models
  • Tested versionContour ProtégéAI configuration described in K213976
Source

K213976 FDA evidence package for Contour ProtégéAI

  • DesignFDA 510(k) decision evidence including CT and MR segmentation model development and verification for the exact production models.
  • PopulationNormal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
  • Scopeexact submission
  • Tested versionContour ProtégéAI configuration described in K213976
  • IndependenceSponsor or vendor study

K213976

Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS radiation-oncology material. Evaluate net planning or delivery value within the radiotherapy service line.
  • Public source
  • Not applicable
  • Checked 2026-09-04

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Build a local total-cost and value model and verify payer, site-of-service, coding, and coverage assumptions independently.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K213976 by exact native submission identifier. This does not exclude product-family, later, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
26Fields reviewed
10Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact-name and exact-submission searches in the checked 2026-09-01 indexes returned no PubMed records and no ClinicalTrials.gov records for K213976; review status is candidate_review_pending. Literature and registry candidates remain quarantined unless exact submission and tested-version linkage is established. The checked recall disposition is no exact-submission recall record was promoted; ambiguous or family-only candidates are not published. Pricing, complete security architecture, contracted deployment, exact reimbursement, and local interoperability remain unverified. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) decision material K213976: Contour ProtégéAI

    U.S. Food and Drug Administration - Published 2022-02-03 - Accessed 2026-09-04

    Scope: identity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  6. Radiation Oncology Model

    Centers for Medicare & Medicaid Services - Accessed 2026-09-02

    Scope: reimbursement, radiationTherapyPaymentContext

Research history

  1. K213976 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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