Radiology AI Directory

FDA-cleared profile

Contour+ (MVision AI Segmentation)

MVision AI Oy

Authorized purpose: Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified review and approval.

Breast imagingRadiotherapy planning
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified review and approval.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Contour+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified review and approval.

Evidence takeaway

Evidence from the reviewed source record: FDA materials describe release-specific contour verification. Independent and guidance literature shows structure-dependent performance and emphasizes local acceptance, review burden, dosimetric impact, and lifecycle monitoring instead of reliance on average overlap metrics.

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+ generates initial CT and MR anatomical contours across head and neck, brain, breast, thoracoabdominal, and pelvic radiation-treatment planning workflows for qualified review and approval.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
clinicians trained in radiation therapy workflows
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact comparison identifies clinicians trained in radiation therapy workflows and does not enumerate the current dossier's role list.

Care setting and population
Radiation-therapy planning departments in hospitals and clinics.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Initial anatomical contour generation before radiation-treatment planning and professional approval.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
DICOM CT or MR images transferred locally or through a supported cloud workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
Generated anatomical structures for review, editing, approval, and transfer to a treatment-planning workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indication states these two explicit limitations; the packet also requires professional visualization, review, modification, and approval before further clinical use.

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
K241490
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiotherapy Planning Imaging
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-10-18
  • 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
K241490 describes local DICOM TCP/IP exchange and cloud transfer of deidentified DICOM using TLS.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
On-premises or cloud deployment described in the exact FDA summary.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
K241490 describes deidentification and TLS for cloud transfer. Current vendor materials describe pseudonymization and encryption; obtain the exact architecture, access, audit, retention, backup, and incident-response package.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Confirm the controls against the exact contracted architecture and release.

Training and support
Only qualified radiation oncologists, medical physicists, dosimetrists, and trained treatment-planning staff. should operate or interpret the system. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model 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 the limits that matter for this product: Contour+ does not detect tumors and K241490 is not for real-time adaptive treatment. Structure, anatomy, modality, scanner, and release support must be verified, and every contour requires clinical review.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K241490 before acceptance.

exact submission · checked 2026-09-03

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

Source

Interoperability acceptance

K241490 describes local DICOM TCP/IP exchange and cloud transfer of deidentified DICOM using TLS.

exact submission · checked 2026-09-03

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

SourceSource

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. Contour+ does not detect tumors and K241490 is not for real-time adaptive treatment. Structure, anatomy, modality, scanner, and release support must be verified, and every contour requires clinical review.

exact submission · checked 2026-09-03

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 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model 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 the limits that matter for this product: Contour+ does not detect tumors and K241490 is not for real-time adaptive treatment. Structure, anatomy, modality, scanner, and release support must be verified, and every contour requires clinical review.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

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
FDA materials describe release-specific contour verification. Independent and guidance literature shows structure-dependent performance and emphasizes local acceptance, review burden, dosimetric impact, and lifecycle monitoring instead of reliance on average overlap metrics.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K241490 FDA performance package for Contour+ (MVision AI Segmentation)

  • DesignManufacturer locked-model contouring verification across supported CT and MR anatomies
  • PopulationRepresentative head and neck, brain, breast, thoracoabdominal, and pelvic radiotherapy images
  • Scopeexact submission
  • Tested versionContour+ cleared in K241490
  • IndependenceSponsor or vendor study

K241490

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

Source

Guidance on selecting and evaluating AI auto-segmentation systems

  • DesignPeer-reviewed implementation and evaluation guidance
  • PopulationRadiotherapy auto-segmentation selection and deployment
  • Scopeproduct family
  • Tested versionMultiple commercial product families
  • IndependenceIndependent study

PMC11997002

Cross-product guidance; not exact K241490 performance evidence.

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 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, 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 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance.

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 K241490 by exact submission identifier.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields reviewed
12Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, vendor product page, peer reviewed publication, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, 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 K241490: Contour+ (MVision AI Segmentation)

    U.S. Food and Drug Administration - Published 2024-10-18 - Accessed 2026-09-19

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

  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

  7. Artificial intelligence contouring in radiotherapy for organs-at-risk and lymph node areas

    BMC Cancer - Accessed 2026-09-03

    Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring, implementationCapabilities

  8. Guidance on selecting and evaluating AI auto-segmentation systems in clinical radiotherapy

    Journal of Applied Clinical Medical Physics - Accessed 2026-09-03

    Scope: limitations, evidenceSummary, economics, monitoring, implementationCapabilities

  9. Contour+ product-family overview

    MVision AI - Accessed 2026-09-03

    Scope: productFamily, workflowRole, integration, deployment, security, implementationCapabilities, currentCommercialContext

Research history

  1. K241490 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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