Authorized purpose: AI-Rad Companion Organs RT VA70 automatically contours predefined structures, including known diagnosed brain metastases, on DICOM CT and MR images for radiation therapy planning; qualified users must review, edit and accept contours in suitable planning or contouring software, and the device is not intended for diagnosis.
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: AI-Rad Companion Organs RT VA70 automatically contours predefined structures, including known diagnosed brain metastases, on DICOM CT and MR images for radiation therapy planning; qualified users must review, edit and accept contours in suitable planning or contouring software, and the device is not intended for diagnosis.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: AI-Rad Companion Organs RT VA70 automatically contours predefined structures, including known diagnosed brain metastases, on DICOM CT and MR images for radiation therapy planning; qualified users must review, edit and accept contours in suitable planning or contouring software, and the device is not intended for diagnosis.
Which images or clinical context are in scope?Modality: Radiotherapy Planning Imaging Anatomy or clinical context: Head/neck, thorax, abdomen, pelvis; MR brain and male pelvis Input: DICOM CT series for head/neck, thorax, abdomen and pelvis; MR series for brain and male-pelvis structures, including the labeled brain-metastasis workflow.
Who uses it?Intended users: Qualified and trained medical professionals
What does the software produce?Output: DICOM Radiotherapy Structure Set (RTSS) contours; a results preview supports confirmation or rejection before transfer to a configured target node.
What is its most important limitation?Key limitation: Not intended for diagnosis. Brain metastases must already be known/diagnosed. Automatically transferred contours still require review and, where necessary, editing in a TPS or interactive contouring application before treatment-planning use. Models are locked and cannot be modified by users.
Clinical takeaway
Clinical role: AI-Rad Companion Organs RT VA70 automatically contours predefined structures, including known diagnosed brain metastases, on DICOM CT and MR images for radiation therapy planning; qualified users must review, edit and accept contours in suitable planning or contouring software, and the device is not intended for diagnosis.
Evidence takeaway
Evidence from the reviewed source record: Exact-submission validation supports clinician-reviewed segmentation. Older-version independent feasibility evidence does not establish VA70A clinical outcomes or local time savings.
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
AI-Rad Companion Organs RT VA70 automatically contours predefined structures, including known diagnosed brain metastases, on DICOM CT and MR images for radiation therapy planning; qualified users must review, edit and accept contours in suitable planning or contouring software, and the device is not intended for diagnosis.
DICOM CT series for head/neck, thorax, abdomen and pelvis; MR series for brain and male-pelvis structures, including the labeled brain-metastasis workflow.
Not intended for diagnosis. Brain metastases must already be known/diagnosed. Automatically transferred contours still require review and, where necessary, editing in a TPS or interactive contouring application before treatment-planning use. Models are locked and cannot be modified by users.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
DICOM CT/MR input and RTSS output to a configurable DICOM node, typically a TPS or contouring application; optional direct transfer without manual confirmation is described.
FDA source
Exact FDA submission
Checked 2026-09-05
This establishes format and workflow support, not tested interoperability with every local TPS.
The reviewed summary establishes processing and target-node routing, but does not establish the current site's hosting model, region, sizing, retention or service commitments.
Security and privacy
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
Regulatory cybersecurity-process descriptions do not establish current scoped certification, installed access controls, hosting or contractual data protection.
Training and support
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
Qualified trained users are required, but the VA70A onboarding curriculum, competency sign-off and support terms were not established.
Monitoring and change control
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
Editorial acceptance question: how will the site review contour edits, failed cases, target-node routing and model updates? No supplied monitoring service is verified.
Current vendor family workflow context
Siemens describes Organs RT as automatic organ-at-risk contouring and illustrates CT contours exported into treatment-planning workflows.
product family · checked 2026-09-05
Current regional vendor page is family context; availability and installed VA70A configuration require confirmation.
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
Exact-submission validation supports clinician-reviewed segmentation. Older-version independent feasibility evidence does not establish VA70A clinical outcomes or local time savings.
No single transferable diagnostic sensitivity is established by the reviewed contouring evaluations; organ- and algorithm-specific validation must be consulted.
Reported specificity
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-05
No single diagnostic specificity for VA70A is established in this review.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K252548 VA70A software and contouring validation
DesignManufacturer retrospective image-based algorithm validation against manual annotations, literature/cleared-device references and VA60A, plus software verification
PopulationCT datasets acquired for radiotherapy planning across multiple continents; separate MR organ and metastasis datasets
Scopeexact submission
Tested versionAI-Rad Companion Organs RT SW VA70A
IndependenceSponsor or vendor study
K252548
CT evaluation reports N=469; MR datasets have different denominators. No clinical tests were conducted for the modifications; no aggregate diagnostic accuracy is inferred.
Feasibility evaluation of novel AI-based deep-learning contouring algorithm for radiotherapy
DesignRetrospective feasibility comparison of automated and three independent human contour sets, with expert ratings and geometric assessment
Population30 CT patients: ten pelvis, ten thorax and ten head/neck
Scopeproduct family
Tested versionAI-Rad Companion Organs RT VA30A
Samplen=30
IndependenceIndependence not established
PMID 37464581 · DOI 10.1002/acm2.14090
Abstract and conflict statement reviewed; authors declare no conflicts. Funding/support independence was not established. Agreement and editing requirements varied by organ. This is older-version context, not K252548 performance.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Vendor documentation pending
Vendor confirmation
Exact FDA submission
Checked 2026-09-05
No exact VA70A amount, license unit, term or implementation/support price was established from the reviewed material.
Reimbursement and coding
Research pending
Needs research
Exact FDA submission
Checked 2026-09-05
Applicable CMS national/local policy content has not been reviewed; no product-specific payment or coverage determination is made.
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
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
Verify deployment and data flow: The reviewed summary establishes processing and target-node routing, but does not establish the current site's hosting model, region, sizing, retention or service commitments.
Verify security and privacy controls: Regulatory cybersecurity-process descriptions do not establish current scoped certification, installed access controls, hosting or contractual data protection.
Verify training: Qualified trained users are required, but the VA70A onboarding curriculum, competency sign-off and support terms were not established.
Verify pricing and total cost: No exact VA70A amount, license unit, term or implementation/support price was established from the reviewed material.
Verify reimbursement and coding relevance: Applicable CMS national/local policy content has not been reviewed; no product-specific payment or coverage determination is made.
Verify local validation and lifecycle monitoring: Editorial acceptance question: how will the site review contour edits, failed cases, target-node routing and model updates? No supplied monitoring service is verified.
Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-05Last searched
19Fields reviewed
11Source classes checked
8Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
All eight stored titles/dates were screened. PMID 37464581 was additionally read live and retained as VA30A family context. The other seven metadata records do not establish VA70A/K252548 linkage and are not promoted; full-text applicability remains unresolved. No stored trial candidates. 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, literature index, trial registry, fda decision summary, vendor product page, peer reviewed literature, stored candidate metadata, stored recall candidates, 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 history7 sources - 3 history items
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