Radiology AI Directory

FDA-cleared profile

Quantib Brain 1

QUANTIB BV

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.

Quantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct 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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Trained medical professionals, including radiologists or radiology specialists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Structural brain MRI and radiology quantitative-reporting workflow; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Post-processing plugin for automatic segmentation and volumetry; the user reviews, edits, and validates WMH candidates before relying on their volumes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
A 3D T1-weighted MR image plus an additional T2-weighted FLAIR MR image for WMH segmentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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.

FDA submission
K153351
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Brain structures, including grey matter, white matter, cerebrospinal fluid, and white-matter-hyperintensity candidates.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2016-06-17
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

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 2026-09-09
Source

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.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

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
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K153351 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

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.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-09Last searched
17Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

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

  1. FDA K153351: Quantib Brain 1

    U.S. Food and Drug Administration - Published 2016-06-17 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Quantib Brain 1 model card (K153351)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: anatomy

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K153351

    U.S. Food and Drug Administration - Accessed 2026-09-09

    Scope: postmarketSafety

Research history

  1. K153351 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

Alternatives

Related tools to compare

FDA-cleared K163013

Quantib Brain 1.2

Quantib BV

Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides...

Modality
MRI
Anatomy
Brain structures, including grey matter, white matter, cerebrospinal fluid, and white-matter-hyperintensity candidates.
Decision
2017-01-06
Quantification and segmentation
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
Quantification and segmentationNeuro MRI
FDA-cleared K261273

Neurophet AQUA

Neurophet., Inc.

Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric...

Modality
MRI
Anatomy
Brain; segmentable structures and lesions
Decision
2026-05-15
Quantification and segmentation
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
Quantification and segmentationNeuro MRI