FDA-cleared profile
Radformation, Inc.
AutoContour assists radiation treatment planners by generating initial structure contours from medical images for review and modification before radiation-therapy planning. V2 added MR contouring, 58 CT models, six MR models, automatic deformable registration, and a local automatic-contouring processor while retaining the Windows client and DICOM workflow.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Request the current security package and contract controls for the proposed deployment.
V2 added MR contouring, 58 CT models, six MR models, automatic deformable registration, and a local automatic-contouring processor while retaining the Windows client and DICOM workflow. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K220598 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that an earlier cleared release includes them.
Windows client and agent components exchange DICOM images and RT Structure Sets with network storage and treatment-planning systems; later releases add rigid or deformable registration and expanded automatic-routing options.
exact submission · checked 2026-09-03Test representative imports, exports, identifiers, orientation, geometry, structure names, units, failure handling, and round trips in the local environment.
Use a signed local test set spanning supported anatomies, scanners, protocols, unusual or postsurgical anatomy, and small or complex structures. Measure edit burden, rejection, downstream plan effects, and reviewer agreement rather than relying only on average overlap metrics.
product family · checked 2026-09-03Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model total annual and per-plan cost against hands-on and elapsed time after review, correction, failed transfers, rework, support, upgrades, downtime, and any effect on plan quality or throughput.
product family · checked 2026-09-03Vendor time-saving results are scenario inputs, not guaranteed local savings.
Monitor by exact software and model version, anatomy, structure, scanner and protocol, patient position, contrast, unusual or postsurgical anatomy, reviewer role, edit time, rejected outputs, DICOM-transfer failures, downstream plan effects, incidents, recalls, and updates. Revalidate after material workflow or model changes.
product family · checked 2026-09-03Trend failures and edits by exact software version, model, anatomy, scanner, protocol, and site.
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.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
Values reported in the exact-submission materials. Consult the linked source for endpoint, threshold, population, and confidence interval before comparison.
58 models
0.94 DSC
0.82 DSC
0.61 DSC
36.6 minutes
K220598
Manufacturer evidence submitted for substantial equivalence. V2 added MR contouring, 58 CT models, six MR models, automatic deformable registration, and a local automatic-contouring processor while retaining the Windows client and DICOM workflow.
PMID 37601695
The evaluated software differs from later RADAC submissions; reported efficiency cannot be assumed for another version or site.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared release was found. Obtain a written quote separating license basis, sites or users, enabled modules or models, implementation, interfaces, compute, storage, training, support, upgrades, renewal, and exit costs.
No separate named-product payment identified in reviewed CMS material
Centers for Medicare & Medicaid Services · United StatesBuild a local total-cost and value model; do not infer reimbursement from FDA clearance.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists. Maintain ongoing FDA and vendor surveillance.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA decision materials, current product-family materials, directly relevant clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, final security architecture, contracted services, enabled modules or models, interoperability, and local acceptance remain organization-specific evidence. 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, vendor product page, peer reviewed publication, health technology guidance, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: regulatoryIdentity, purpose, modality, anatomy
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: reimbursement, radiationTherapyPaymentContext
Scope: productFamily, integration, deployment, pricingResearch, currentCommercialContext, implementationCapabilities
Scope: security, training, pricing, monitoring, dataGovernance, implementationCapabilities
Scope: limitations, training, pricing, evidenceSummary, economics, monitoring, implementationCapabilities
Scope: evidenceSummary, evidenceStudy, evidenceMetrics, economics, implementationCapabilities
Scope: evidenceSummary, evidenceStudy, evidenceMetrics, implementationCapabilities
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring, implementationCapabilities
Regulatory record
510(k)
Research record
human reviewed
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