Radiology AI Directory

FDA-cleared profile

Neurophet SCALE PET

Neurophet., Inc.

Authorized purpose: Brain MRI/PET registration, segmentation and quantitative PET 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: Brain MRI/PET registration, segmentation and quantitative PET assessment

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Brain MRI/PET registration, segmentation and quantitative PET assessment

Evidence takeaway

Evidence from the reviewed source record: Regulatory testing includes 64 manually referenced MRI segmentation cases, 50 MRI pairs for reproducibility, 74 paired PET/MRI cases for SUVR comparison and 176 amyloid-PET/MRI cases for Centiloid assessment. Separate family publications do not establish exact-version performance.

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
Brain MRI/PET registration, segmentation and quantitative PET assessment
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Medical professionals interpreting and quantitatively assessing brain MRI and PET
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult brain imaging assessment on medical imaging workstations
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Workflow role
Measurement or quantification
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
DICOM brain 3D T1-weighted MRI and amyloid PET or FDG PET
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Brain segmentations, registered/fused images, SUV/SUVR and Centiloid measurements, color-mapped regional displays and DICOM reports
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
Quantification supports clinician assessment rather than autonomous dementia diagnosis. MRI/PET processing and interpretation depend on the specified tracer and workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K252563
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Radiological images; modality varies or is not specified in FDA list
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Existing broad catalog category retained because the controlled vocabulary has no combined MRI/PET entry. The summary specifically requires 3D T1-weighted MRI and amyloid or FDG PET; this is not an unknown input modality.

Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-05-15
  • 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
DICOM inputs and outputs; results can be displayed on DICOM workstations and PACS
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Hosting topology, processing location and licensed workstation/server configuration were not established for a purchased US version.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

No scoped dated attestation, retention schedule or hosting agreement was reviewed.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Tracer-specific onboarding and acceptance criteria require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Update validation and site-level tracer/registration failure monitoring remain unestablished.

Family quantitative PET workflow

Vendor describes automated registration and SUVR/Centiloid analysis

product family · checked 2026-09-05

The current Korean page also describes PET/CT and PET-only workflows; those are not promoted as K252563 MRI/PET capabilities.

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
Regulatory testing includes 64 manually referenced MRI segmentation cases, 50 MRI pairs for reproducibility, 74 paired PET/MRI cases for SUVR comparison and 176 amyloid-PET/MRI cases for Centiloid assessment. Separate family publications do not establish exact-version performance.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

A single clinically interpretable sensitivity for the cleared multipurpose quantification workflow was not established by the reviewed summary.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-05

Segmentation and quantification agreement results do not establish a product-wide diagnostic specificity.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

K252563 MRI segmentation validation

  • DesignStandalone comparison with manual segmentation by four experts
  • PopulationBrain T1-weighted MRI test cases
  • Scopeexact submission
  • Tested versionSCALE PET submitted in K252563; numbered release not specified
  • Samplen=64
  • IndependenceIndependence not established

K252563

Preserves the baseline 64-case study and adds separate PET/registration cohorts in evidenceSummary; cohorts must not be pooled.

Source

Comparison of Amyloid-PET Analysis Software Using 18F-Florbetaben PET in Patients with Cognitive Impairment

  • DesignRetrospective cross-software comparison
  • Population129 cognitively impaired patients: 39 Alzheimer disease and 90 non-Alzheimer disease
  • Scopeproduct family
  • Tested versionSCALE PET; exact software version not established in reviewed abstract
  • Samplen=129
  • IndependenceIndependence not established

PMID:40870879 · doi:10.3390/diagnostics15162028

Compares regional SUVR with MIMneuro and CortexID. Agreement between software packages is not exact-K252563 diagnostic accuracy.

Source

DTI-ALPS associations with regional amyloid deposition and glucose metabolism in mild cognitive impairment and Alzheimer's disease

  • DesignObservational biomarker association study
  • Population34 Alzheimer disease, 40 mild cognitive impairment and 52 controls
  • Scopeproduct family
  • Tested versionSCALE PET used for PET quantification; exact version not established
  • Samplen=126
  • IndependenceIndependence not established

PMID:42379471 · doi:10.1016/j.neurad.2026.101586

Contextual research use, not a standalone validation of the submitted software.

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 2026-09-05

Reviewed product material did not establish an exact-version US license or per-analysis rate.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable payer policy was reviewed; PET procedure payment does not establish payment for this software.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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

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.

Human reviewedStatus
2026-09-05Last searched
19Fields reviewed
11Source classes checked
2Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

Both PubMed records name SCALE PET and are retained as family contextual studies. NCT07417540 metadata identifies a Neurophet quantitative brain PET evaluation, but live registry returned a JavaScript shell; methods, outcomes and exact version remain unverified. The current discovery snapshot contains 2 PubMed and 1 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, acr ai central product, fda decision summary, vendor product page, literature index, peer reviewed publication, trial registry, recall database, 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. K252563 FDA decision source

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

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. Neurophet SCALE PET model card (K252563)

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

    Scope: intendedUsers, careSetting, output, 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. Neurophet SCALE PET: K252563 decision and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, evidence, implementation

  8. Neurophet SCALE PET solutions

    Neurophet - Accessed 2026-09-05

    Scope: implementation

  9. Comparison of Amyloid-PET Analysis Software Using 18F-Florbetaben PET in Patients with Cognitive Impairment

    Diagnostics / PubMed - Published 2025-08-13 - Accessed 2026-09-05

    Scope: evidenceStudies

  10. DTI-ALPS associations with regional amyloid deposition and glucose metabolism in mild cognitive impairment and Alzheimer's disease

    Journal of Neuroradiology / PubMed - Published 2026-06-30 - Accessed 2026-09-05

    Scope: evidenceStudies

Research history

  1. K252563 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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