Radiology AI Directory

FDA-cleared profile

Neurophet AQUA

NEUROPHET, Inc.

Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with optional comparison of volumetric data to reference percentile data; a support tool for structural-MRI assessment.

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.

Product overview

Start with the essentials

Authorized purpose: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with optional comparison of volumetric data to reference percentile data; a support tool for structural-MRI assessment.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with optional comparison of volumetric data to reference percentile data; a support tool for structural-MRI assessment.

Evidence takeaway

Evidence from the reviewed source record: FDA performance testing used 300 T1-weighted scans from 10 scanner types for training, 64 T1 scans for accuracy, and 50 repeated T1 scans for reproducibility, with testing separate from training. Dice coefficients were 80-90% for major subcortical structures and 75-85% for major cortical regions; mean percentage absolute volume differences for major subcortical structures were 1-5%. These are segmentation-agreement and reproducibility endpoints, not sensitivity, specificity, or AUC.

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, with optional comparison of volumetric data to reference percentile data; a support tool for structural-MRI assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Clinicians and physicians skilled in brain MR imaging; results must be reviewed by a trained physician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Routine patient care and clinical-trial research as a structural-MRI support workflow; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Automated post-processing segmentation, volumetry, morphometric reporting, and protocol-quality checking with trained-physician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
MR brain images, including 3D T1 MRI series acquired under specified protocols; DICOM is supported as input.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Segmented images with color overlays, volumetric measurements, morphometric reports, reference-percentile comparisons, a dedicated GUI for reviewing measures, a printable PDF report, and DICOM output displayable on DICOM workstations and PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Results must be reviewed by a trained physician. Automated quality controls include tissue-contrast checks and scan-protocol verification; the FDA packet establishes a support tool and segmentation/measurement evidence, not a diagnostic-outcome claim.
  • 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
K220437
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Segmentable brain structures.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-05-10
  • 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
Installed Windows software on off-the-shelf hardware with DICOM input/output, a dedicated GUI, and reports displayable on DICOM workstations and PACS; the FDA packet does not establish current cloud hosting.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-cloud
  • 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.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Neurophet AQUA; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · 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 performance testing used 300 T1-weighted scans from 10 scanner types for training, 64 T1 scans for accuracy, and 50 repeated T1 scans for reproducibility, with testing separate from training. Dice coefficients were 80-90% for major subcortical structures and 75-85% for major cortical regions; mean percentage absolute volume differences for major subcortical structures were 1-5%. These are segmentation-agreement and reproducibility endpoints, not sensitivity, specificity, or AUC.
  • 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.

Neurophet AQUA 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 K220437
  • Samplen=114
  • IndependenceIndependence not established

K220437

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

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 K220437 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 K220437. 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
2026-09-20Last searched
23Fields reviewed
9Source classes checked
6Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 6 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 6 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

  1. FDA K220437: Neurophet AQUA

    U.S. Food and Drug Administration - Published 2023-05-10 - 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. Neurophet AQUA model card (K220437)

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

    Scope: intendedUsers, output, limitations, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  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 K220437

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

    Scope: postmarketSafety

Research history

  1. K220437 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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