FDA-cleared profile
Quantib BV
Authorized purpose: Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional review.
Product overview
Authorized purpose: Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional review.
Overview status: Source-reviewed overview
Clinical role: Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional review.
Evidence from the reviewed source record: The exact FDA submission K182564 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
Clinical details
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Medical image analysis, visualization, measurement, triage, or reporting support as specified by the exact submission.
exact submission · checked 2026-09-04This is a submission-anchored intended-use summary, not a local acceptance result.
Supported DICOM images, metadata, and release-specific workflow inputs.
exact submission · checked 2026-09-04Exact supported inputs and protocol limits must be confirmed from the complete labeling.
Processed images, measurements, annotations, notifications, or reports for professional review.
exact submission · checked 2026-09-04Output review, editing, and downstream use remain release- and site-specific.
Current vendor material is product-family context for K182564 only; exact release, enabled options, deployment, and local interoperability require confirmation.
product family · checked 2026-09-04Vendor material is not exact-release evidence unless that linkage is separately proven.
Exact local interfaces, deployment topology, security controls, downtime behavior, and support obligations remain unestablished.
exact submission · checked 2026-09-04Obtain organization-specific implementation evidence before procurement or clinical use.
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.
No exact submission and version-linked sensitivity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.
No exact submission and version-linked specificity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
K182564
FDA regulatory evidence is submission-specific but is not independent clinical performance evidence.
3 unlinked candidate evidence records are retained for source review and excluded from this evidence display.
Costs and setup
These are common procurement questions; unknown values remain visible until a source supports them.
No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.
CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
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
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The refreshed discovery snapshot contains 3 PubMed and 0 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 3 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, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall
Sources & history
Open the ledger for source dates, scope, and research-record updates.
Scope: regulatoryIdentity, productIdentity, indication, modality, anatomy, workflowRole, input, output, limitations, evidenceSummary
Scope: regulatoryIdentity, modalityContext
Scope: evidenceDiscovery
Scope: evidenceDiscovery, studyStatus
Scope: coverage, codingContext
Scope: recallDiscovery, nativeSubmissionMatching
Scope: productFamilyContext, workflowRole, implementationCapabilities
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Scope: evidenceStudies, productFamilyContext, evidenceDiscovery
Regulatory record
510(k)
Research record
fda record reviewed
Editorial review
Source-reviewed editorial overlay
Alternatives
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...
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...
Siemens Healthcare GmbH
Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
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...