FDA-cleared profile
Siemens Medical Solutions USA, Inc
Authorized purpose: AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29 head-and-neck structures and does not detect or contour lesions.
Product overview
Authorized purpose: AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29 head-and-neck structures and does not detect or contour lesions.
Overview status: Source-reviewed overview
Clinical role: AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29 head-and-neck structures and does not detect or contour lesions.
Evidence from the reviewed source record: FDA summaries describe locked algorithms, software verification, DICOM testing, and release-specific validation of added structures. A multi-institutional publication and a blinded multi-vendor study support clinical usability while showing organ-level variation and continuing need for expert review; neither establishes autonomous use or patient-outcome benefit.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.
The exact indication states that RTSTRUCT outputs are intended to be used by trained medical professionals.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
These workflow, lesion, and adult-input boundaries are stated directly in the exact indication and device description.
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.
The exact indication and device description identify DICOM CT input and the external-beam radiation-therapy planning workflow. Controlled directory display reconciled from exact FDA wording: CT imaging data in DICOM format for external beam radiation therapy treatment planning. -> Radiotherapy Planning Imaging.
Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request architecture, data flow, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
VA40 added analysis of 29 head-and-neck structures while retaining locked CT models and mandatory review in a treatment-planning or interactive-contouring application. Procurement should map the installed build, modules, models, anatomies, inputs, and outputs to K221305 before acceptance.
exact submission · checked 2026-09-03Later product-family features are not evidence that an earlier cleared release includes them.
DICOM CT or MR input, DICOM RTSTRUCT output, configurable DICOM-node transfer, organ-template configuration, and a web-based confirmation interface.
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.
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.
29 structures
33 organs
19 organs
K221305
Manufacturer evidence submitted for substantial equivalence. VA40 added analysis of 29 head-and-neck structures while retaining locked CT models and mandatory review in a treatment-planning or interactive-contouring application.
PMID 39023610
Nineteen structures averaged at least 3.5 on a four-point scale and the remainder at least 3.0; review author affiliations and exact software version before procurement use.
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.
The refreshed discovery snapshot contains 8 PubMed and 0 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 8 PubMed and 0 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, health technology guidance, reimbursement policy, fda device recall, fda decision summary packet, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: purpose, anatomy, input, output, modality, intendedUsers, limitations, evidenceSummary, clinicalUse
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: recallDiscovery, nativeSubmissionMatching
Scope: reimbursement, radiationTherapyPaymentContext
Scope: limitations, training, pricing, evidenceSummary, economics, monitoring, implementationCapabilities
Scope: productFamily, workflowRole, integration, deployment, currentCommercialContext, implementationCapabilities
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring, implementationCapabilities
Scope: limitations, evidenceSummary, evidenceStudy, evidenceMetrics, monitoring, implementationCapabilities
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Organs RT VA20 automatically contours predefined organs at risk from adult DICOM CT for qualified review, editing, and DICOM RTSTRUCT transfer into...
Radformation, Inc.
AutoContour Model RADAC V5 assists radiation treatment planners with contouring and reviewing structures in medical images for radiation therapy treatment planning. It produces...
Elekta Solutions AB
The EMLA family delivers external-beam radiation therapy for adult and pediatric patients with benign, malignant, or metastatic disease. Authorized techniques vary by model:...
Therapanacea Sas
ART-Plan+ assists trained radiation-therapy professionals with multimodal image review, registration, contouring, and the release-specific planning functions described in K253091....