Radiology AI Directory

FDA-cleared profile

Alzevita

TOPIA MEDTECH LIMITED

Authorized purpose: Automated hippocampal labeling, visualization, and volumetric measurement from high-resolution T1-weighted brain MRI, with comparison to a normative healthy-control dataset acquired using standardized 1.5T/3T protocols.

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: Automated hippocampal labeling, visualization, and volumetric measurement from high-resolution T1-weighted brain MRI, with comparison to a normative healthy-control dataset acquired using standardized 1.5T/3T protocols.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Automated hippocampal labeling, visualization, and volumetric measurement from high-resolution T1-weighted brain MRI, with comparison to a normative healthy-control dataset acquired using standardized 1.5T/3T protocols.

Evidence takeaway

Evidence from the reviewed source record: The FDA packet describes a 200-case training set from India acquired at 1.5T and an independent 298-subject ADNI validation set using 1.5T/3T 3D T1 MPRAGE; three radiologists established a STAPLE consensus ground truth. Overall validation Dice was 0.86 (95% CI 0.85-0.86) and Hausdorff distance was 1.51 mm (1.43-1.59). The stated acceptance criteria were Dice >=75%, Hausdorff distance <=6.1 mm, correlation coefficient >=0.82, relative volume difference <=24.6%, and Bland-Altman mean difference <=1010 mm3; subgroup results were also reported.

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
Automated hippocampal labeling, visualization, and volumetric measurement from high-resolution T1-weighted brain MRI, with comparison to a normative healthy-control dataset acquired using standardized 1.5T/3T protocols.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Neurologists and radiologists experienced in interpreting and analyzing brain MRI scans
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Professional neuroimaging workflow through a secure web interface
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing hippocampal segmentation and measurement/quantification
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
High-resolution T1-weighted 3D MRI scans in compressed DICOM or NIfTI format; the FDA validation used 3D T1 MPRAGE at 1.5T and 3T with 1.0 or 1.2 mm slice thickness. The normative control dataset covers ages 55-90; this is a reference-dataset age range, not an explicit patient-age restriction in the indication.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automated hippocampal labels/segmentations, visualization, hippocampal-volume measurements, and a visual/tabular volumetric analysis report in the web MRI viewer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Results require review by a trained clinician/radiologist/neurologist. The indication specifies standardized high-resolution T1-weighted protocols and a normative reference dataset but does not state a patient-age restriction or a disease-diagnosis indication. FDA materials do not establish clinical performance outside the described imaging conditions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K252670
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Brain; hippocampus
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-12-19
  • 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
Secure web interface compatible with common operating systems and browsers; accepts compressed DICOM or NIfTI and displays images in an MRI viewer. The FDA packet does not establish a specific PACS, RIS, EHR, or network interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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 2026-09-08

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 2026-09-08

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 2026-09-08

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

ACR exact-submission catalog context

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

exact submission · checked 2026-09-08
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
The FDA packet describes a 200-case training set from India acquired at 1.5T and an independent 298-subject ADNI validation set using 1.5T/3T 3D T1 MPRAGE; three radiologists established a STAPLE consensus ground truth. Overall validation Dice was 0.86 (95% CI 0.85-0.86) and Hausdorff distance was 1.51 mm (1.43-1.59). The stated acceptance criteria were Dice >=75%, Hausdorff distance <=6.1 mm, correlation coefficient >=0.82, relative volume difference <=24.6%, and Bland-Altman mean difference <=1010 mm3; subgroup results were also reported.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
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.

Alzevita regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K252670
  • Samplen=298
  • IndependenceIndependence not established

K252670

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 2026-09-08

No public price or quote for the exact K252670 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K252670. 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 2026-09-08

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
24Fields 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

  1. FDA K252670: Alzevita

    U.S. Food and Drug Administration - Published 2025-12-19 - Accessed 2026-09-08

    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. Alzevita model card (K252670)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, 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 K252670

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K252670 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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