Input or output interoperability
DICOM is explicitly referenced in the described input, output, or workflow.
exact submission · checked 2026-09-01The model card does not establish every supported DICOM object, transfer method, or local interface.
FDA-cleared profile
ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.
Authorized purpose: Automatically labels, visualizes, and quantifies the volume and shape of segmentable brain structures from MR images.
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: Automatically labels, visualizes, and quantifies the volume and shape of segmentable brain structures from MR images.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatically labels, visualizes, and quantifies the volume and shape of segmentable brain structures from MR images.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain Input: DICOM T1-weighted brain MR scans.
- Who uses it? Intended users: Medical professionals such as radiologists, neurologists, and neuroradiologists.
- What does the software produce? Output: Automated labels, color-coded overlays or 3D meshes, volume and shape measurements, DICOM results, and PDF reports with normative comparisons.
- What is its most important limitation? Key limitation: Limited to segmentable brain structures from T1-weighted brain MRI; additional exact FDA limitations are unknown.
Clinical takeaway
Clinical role: Automatically labels, visualizes, and quantifies the volume and shape of segmentable brain structures from MR images.
Evidence takeaway
Evidence from the reviewed source record: FDA summary reports validation in 101 subjects across 21 structures, with Dice and relative-volume acceptance criteria; third-ventricle mean Dice was below 0.70, and repeat-scan reproducibility was under 10% in the 20Repeat set.
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
- Automatically labels, visualizes, and quantifies the volume and shape of segmentable brain structures from MR images.
Clinical-use display mirrors the exact FDA-supported purpose reconciled in this remediation finding.
- Intended users
- Medical professionals such as radiologists, neurologists, and neuroradiologists.
FDA packet intended-user statement.
- Care setting and population
- Research pending
Confirm the intended care setting, patient population, and service line.
- Workflow role
- Segmentation or contouring
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- DICOM T1-weighted brain MR scans.
FDA device description and comparison table.
- Output and human action
- Automated labels, color-coded overlays or 3D meshes, volume and shape measurements, DICOM results, and PDF reports with normative comparisons.
FDA device description.
- Limitations
- Limited to segmentable brain structures from T1-weighted brain MRI; additional exact FDA limitations are unknown.
Packet states the segmentable-structure and T1-weighted scope but no broader limitation list.
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
- The exact-submission ACR model card explicitly references DICOM in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- Vendor documentation pending
The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Security and privacy
- Vendor documentation pending
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Supported acquisition environment
Scanner manufacturers: All
exact submission · checked 2026-09-01Confirm currently supported software versions, protocols, and site-specific acquisition configurations.
ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for ClearPoint Maestro Brain Model; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-09Evidence
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
- FDA summary reports validation in 101 subjects across 21 structures, with Dice and relative-volume acceptance criteria; third-ventricle mean Dice was below 0.70, and repeat-scan reproducibility was under 10% in the 20Repeat set.
Submission-reported segmentation validation; not a general clinical-outcomes claim.
- Reported sensitivity
- Research pending
This field has not been curated yet.
- Reported specificity
- Research pending
This field has not been curated yet.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
ClearPoint Maestro Brain Model regulatory performance study summary
- DesignStand-Alone Performance
- PopulationPopulation described in the exact-submission ACR model card
- Scopeexact submission
- Tested versionExact product version not reported; regulatory study summarized for FDA submission K213645
- Samplen=101
- IndependenceIndependence not established
K213645
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K213645 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
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
- The exact-identifier FDA recall query returned no native recall record for K213645. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
Buyer worksheet
Open questions to take to the vendor
- Verify care setting and population: Confirm the intended care setting, patient population, and service line.
- Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K213645 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
23Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 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, acr ai central product, fda device recall, literature index, trial registry, fda decision summary packet, 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
-
FDA K213645: ClearPoint Maestro Brain Model
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, purpose, intendedUsers, input, output, limitations, evidenceSummary
-
Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
-
ClearPoint Maestro Brain Model model card (K213645)
Scope: intendedUsers, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
-
PubMed biomedical literature index
Scope: evidenceDiscovery
-
ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
-
openFDA exact recall query for K213645
Scope: postmarketSafety
Research history
-
K213645 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
Related tools to compare
FDA-cleared K261405
ANDI 2.2
Imeka Solutions, Inc.
ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2026-05-28
FDA-cleared K260032
Morph
BeauBrain Healthcare, Inc.
Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2026-05-13
FDA-cleared K253057
AI-Rad Companion Brain MR
Siemens Healthcare GmbH
Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2026-01-22
FDA-cleared K252298
ANDI 2.0
Imeka Solutions, Inc.
Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical...
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2025-10-22