PACS output
Maps and numeric/visual reports can be exported to PACS.
exact submission · checked 2026-09-06FDA-cleared profile
AI-Rad Companion Brain MR
Siemens Healthcare GmbH
Authorized purpose: Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
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: Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain Input: T1 MPRAGE for brain morphometry. The VA60 comparison table specifies T2-weighted 3D FLAIR alone for WMH, with WMH follow-up at 1.5 T and 3 T and Siemens, GE and Philips inputs.
- Who uses it? Intended users: Healthcare professionals familiar with post-processing magnetic resonance images.
- What does the software produce? Output: Absolute and normalized brain-structure volumes, age-matched normative comparisons and deviation/label maps; WMH count and volume in four brain regions, maps of new or enlarged WMH on follow-up, and numeric/visual reports sent to PACS.
- What is its most important limitation? Key limitation: Quantitative post-processing assists clinician evaluation. WMH follow-up permits changes in field strength, pixel spacing and slice thickness in VA60; a field-strength difference produces an information message.
Clinical takeaway
Clinical role: Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
Evidence takeaway
Evidence from the reviewed source record: VA60 WMH testing used 100 subjects and follow-up testing used 165 subjects, with manually annotated reference data. Morphometry and morphometry follow-up were unchanged from the predicate. Testing supports the modified quantitative features, not a new prospective outcome benefit.
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
- Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
- Intended users
- Healthcare professionals familiar with post-processing magnetic resonance images.
- Care setting and population
- Adult
Baseline population label retained; it is not a claim that all modules have identical age restrictions.
- Workflow role
- Segmentation, quantitative post-processing and follow-up comparison
- Required input
- T1 MPRAGE for brain morphometry. The VA60 comparison table specifies T2-weighted 3D FLAIR alone for WMH, with WMH follow-up at 1.5 T and 3 T and Siemens, GE and Philips inputs.
The specific VA60 input-data row streamlines the predecessor T1-plus-FLAIR requirement, although introductory prose still repeats the older combination. Do not use the older VA51 manual as the VA60 acquisition specification.
- Output and human action
- Absolute and normalized brain-structure volumes, age-matched normative comparisons and deviation/label maps; WMH count and volume in four brain regions, maps of new or enlarged WMH on follow-up, and numeric/visual reports sent to PACS.
- Limitations
- Quantitative post-processing assists clinician evaluation. WMH follow-up permits changes in field strength, pixel spacing and slice thickness in VA60; a field-strength difference produces an information message.
This does not establish unrestricted mixing of acquisitions or that normative values from different software tools are interchangeable.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Generated maps and reports can be exported to PACS; the summary describes confirmation and configuration UI components.
- Deployment and data flow
- Cloud solution and edge components on customer premises.
- Security and privacy
- Vendor documentation pending
Exact-release data flows, hosting region, retention and scoped dated security certification remain unresolved; regulatory software testing is not current operational assurance.
- Training and support
- Vendor documentation pending
A predecessor data sheet is available, but exact VA60 onboarding, competency and support terms were not verified.
- Monitoring and change control
- Vendor documentation pending
Processing-status notifications in predecessor documentation do not establish clinical drift monitoring for VA60.
Predecessor review workflow
VA51 vendor data sheet describes browser confirm/reject, automatic PACS routing and optional processing-status notifier; current VA60 configuration requires confirmation.
product family · checked 2026-09-06Evidence
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
- VA60 WMH testing used 100 subjects and follow-up testing used 165 subjects, with manually annotated reference data. Morphometry and morphometry follow-up were unchanged from the predicate. Testing supports the modified quantitative features, not a new prospective outcome benefit.
Preserves the baseline 100-subject cohort and adds the separately described 165-subject follow-up cohort; these are not pooled as unique patients.
- Reported sensitivity
- Not established in reviewed sources
No product-wide VA60 clinical sensitivity is promoted. Segmentation/follow-up endpoints and an older tool-to-tool volumetry study are not interchangeable with diagnosis.
- Reported specificity
- Not established in reviewed sources
No product-wide VA60 clinical specificity is established by the reviewed evidence.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K253057 WMH segmentation validation
- DesignStandalone evaluation against manually annotated ground truth from three radiologists
- Population100 subjects including multiple sclerosis, Alzheimer disease, cognitive impairment and healthy controls; 1.5 T/3 T Siemens, GE and Philips MRI
- Scopeexact submission
- Tested versionAI-Rad Companion Brain MR VA60 WMH feature
- Samplen=100
- IndependenceSponsor or vendor study
K253057
K253057 WMH follow-up validation
- DesignStandalone new/enlarged WMH evaluation against annotated longitudinal reference data
- Population165 subjects with multiple sclerosis or Alzheimer disease scanned at 1.5 T/3 T on Siemens, GE and Philips systems
- Scopeexact submission
- Tested versionAI-Rad Companion Brain MR VA60 WMH follow-up
- Samplen=165
- IndependenceSponsor or vendor study
K253057
Validity Assessment of an Automated Brain Morphometry Tool for Patients with De Novo Memory Symptoms
- DesignRetrospective comparison with FreeSurfer 7.1.1/Individual Longitudinal Participant processing and clinical impressions
- PopulationT1-weighted MRI from 45 OASIS-4 participants with de novo memory symptoms
- Scopeproduct family
- Tested versionAI-Rad Companion Brain MR; no VA60 linkage in reviewed abstract
- Samplen=45
- IndependenceIndependence not established
PMID:36797031 · DOI:10.3174/ajnr.A7790
Strong correlation did not imply agreement of absolute volumes or standardized values across tools. No VA60 diagnostic sensitivity/specificity is inferred. Full-text disclosure review remains incomplete.
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
- Vendor documentation pending
VA60 module, cloud/edge infrastructure, PACS integration and service prices are not established from reviewed materials.
- Reimbursement and coding
- Research pending
No applicable payer coverage/payment policy reviewed for automated brain volumetry or WMH quantification.
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
Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release data flows, hosting region, retention and scoped dated security certification remain unresolved; regulatory software testing is not current operational assurance.
- Verify training: A predecessor data sheet is available, but exact VA60 onboarding, competency and support terms were not verified.
- Verify pricing and total cost: VA60 module, cloud/edge infrastructure, PACS integration and service prices are not established from reviewed materials.
- Verify reimbursement and coding relevance: No applicable payer coverage/payment policy reviewed for automated brain volumetry or WMH quantification.
- Verify local validation and lifecycle monitoring: Processing-status notifications in predecessor documentation do not establish clinical drift monitoring for VA60.
- Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-06Last searched
20Fields reviewed
11Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
Stored metadata screened September 5. Primary author-institution abstract reviewed September 6 after PubMed/PMC verification barriers; retained as 45-participant family volumetry study, not VA60 results. Stored trial array was empty. The current discovery snapshot contains 1 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, acr ai central product, fda decision summary, vendor technical documentation, peer reviewed literature, literature index, trial registry, stored candidate metadata, 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
-
AI-Rad Companion Brain MR VA60: K253057 clearance and summary
Scope: purpose, clinicalUse, modality, anatomy, input, output, limitations, deployment, integration, evidenceStudies
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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AI-Rad Companion Brain MR model card (K253057)
Scope: purpose, modality, intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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AI-Rad Companion Brain MR VA51 data sheet, valid January 2025
Scope: productFamilyContext, implementationCapabilities
-
Validity Assessment of an Automated Brain Morphometry Tool for Patients with De Novo Memory Symptoms
Scope: evidenceStudies, productFamilyContext
Research history
-
K253057 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
human reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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