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. The initial cleared release generated CT structure contours through a cloud service and returned DICOM RT Structure Sets for review, editing, and treatment-planning use.
Clinical fit
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.
The initial cleared release generated CT structure contours through a cloud service and returned DICOM RT Structure Sets for review, editing, and treatment-planning use. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K200323 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.
Sensitivity is not an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, and release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.
Specificity is not an applicable primary endpoint for this radiation-planning software. Review structure-, model-, workflow-, and release-specific geometric, clinical-review, dosimetric, and edit-burden evidence instead.
Mean time saved in the timing subset in AutoContour v1.0.25.0 product-family study.
Tested version: AutoContour v1.0.25.0Manufacturer nonclinical contour-model validation using held-out or independent images, structure-size DSC criteria, expert review, and release-dependent regression testing · Release-specific CT or MR structures and image sets described in the FDA summary
exact submission · Tested version: Initial AutoContour release cleared in K200323 · Sponsor or vendor studyK200323
Manufacturer evidence submitted for substantial equivalence. The initial cleared release generated CT structure contours through a cloud service and returned DICOM RT Structure Sets for review, editing, and treatment-planning use.
Independent retrospective multi-product evaluation with geometric, qualitative, and timing endpoints · 80 radiotherapy patients and 45 structures
product family · Tested version: AutoContour v1.0.25.0 · n=80 · 1 site · Independent studyPMID 37601695
The evaluated software differs from later RADAC submissions; reported efficiency cannot be assumed for another version or site.
Economics and lifecycle
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 20 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
Sources accessed through 2026-09-02.
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