ACR exact-submission catalog context
ACR AI Central provides an exact-submission model card for Quantib Brain 1; FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission ยท checked 2026-09-09FDA-cleared profile
Quantib Brain 1
QUANTIB BV
Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides complementary information for trained medical professionals evaluating MR brain images and preparing quantitative reports.
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: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides complementary information for trained medical professionals evaluating MR brain images and preparing quantitative reports.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides complementary information for trained medical professionals evaluating MR brain images and preparing quantitative reports.
- Which images or clinical context are in scope? Modality: MRI Anatomy or clinical context: Brain structures, including grey matter, white matter, cerebrospinal fluid, and white-matter-hyperintensity candidates. Input: A 3D T1-weighted MR image plus an additional T2-weighted FLAIR MR image for WMH segmentation.
- Who uses it? Intended users: Trained medical professionals, including radiologists or radiology specialists.
- What does the software produce? Output: Segmentations, visualizations, absolute and relative volumetric measurements for grey matter, white matter, CSF, and intracranial volume, plus WMH candidate visualization, total WMH volume, and WMH count.
- What is its most important limitation? Key limitation: WMH candidates must be reviewed and, if necessary, edited by the user before validation; output is complementary information for a trained medical professional. The cleared workflow is a GE Advantage Workstation/AW Server plugin with the stated platform versions.
Clinical takeaway
Clinical role: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides complementary information for trained medical professionals evaluating MR brain images and preparing quantitative reports.
Evidence takeaway
Evidence from the reviewed source record: FDA testing compared automatic and manual segmentations. For 33 T1-weighted scans, Dice indices were CSF 0.78 +/- 0.05, GM 0.83 +/- 0.02, WM 0.86 +/- 0.02, and ICV 0.97 +/- 0.01; the WMH protocol used 30 T1/FLAIR datasets and reported Dice 0.61 +/- 0.13 with relative-volume difference 0.6 +/- 0.7 percentage points. These are segmentation/volume-agreement endpoints, not sensitivity, specificity, AUC, or diagnostic outcomes.
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
- Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides complementary information for trained medical professionals evaluating MR brain images and preparing quantitative reports.
- Intended users
- Trained medical professionals, including radiologists or radiology specialists.
- Care setting and population
- Structural brain MRI and radiology quantitative-reporting workflow; the FDA packet does not specify a facility type.
- Workflow role
- Post-processing plugin for automatic segmentation and volumetry; the user reviews, edits, and validates WMH candidates before relying on their volumes.
- Required input
- A 3D T1-weighted MR image plus an additional T2-weighted FLAIR MR image for WMH segmentation.
- Output and human action
- Segmentations, visualizations, absolute and relative volumetric measurements for grey matter, white matter, CSF, and intracranial volume, plus WMH candidate visualization, total WMH volume, and WMH count.
- Limitations
- WMH candidates must be reviewed and, if necessary, edited by the user before validation; output is complementary information for a trained medical professional. The cleared workflow is a GE Advantage Workstation/AW Server plugin with the stated platform versions.
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
- Post-processing plugin for GE Advantage Workstation AW 4.7 or AW Server AWS 3.2 using Volume Viewer Apps 12.3 Ext 6; the FDA packet does not establish a generic All-PACS interface.
- Deployment and data flow
- On-premise
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- 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.
Evidence
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 testing compared automatic and manual segmentations. For 33 T1-weighted scans, Dice indices were CSF 0.78 +/- 0.05, GM 0.83 +/- 0.02, WM 0.86 +/- 0.02, and ICV 0.97 +/- 0.01; the WMH protocol used 30 T1/FLAIR datasets and reported Dice 0.61 +/- 0.13 with relative-volume difference 0.6 +/- 0.7 percentage points. These are segmentation/volume-agreement endpoints, not sensitivity, specificity, AUC, or diagnostic outcomes.
- 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.
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 K153351 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 K153351. 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 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 K153351 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
18Fields reviewed
9Source 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, 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
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FDA K153351: Quantib Brain 1
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Quantib Brain 1 model card (K153351)
Scope: anatomy
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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openFDA exact recall query for K153351
Scope: postmarketSafety
Research history
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K153351 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
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