Radiology AI Directory

FDA-cleared profile

SwiftSight-Brain

AIRS Medical Inc.

Adjunctive brain MRI morphometry and lesion-quantification support for qualified healthcare professionals, including segmented overlays, volumetric measurements, normative percentiles and longitudinal comparison.

Quantification and segmentationNeuro MRI
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
Adjunctive brain MRI morphometry and lesion-quantification support for qualified healthcare professionals, including segmented overlays, volumetric measurements, normative percentiles and longitudinal comparison.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Intended users
Radiologists, neurologists and other qualified healthcare professionals interpreting brain MRI.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Care setting and population
Healthcare neuroimaging services using supported brain MRI protocols.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Workflow role
Automated quantitative and visualization aid; results are reviewed by a qualified medical professional and do not replace clinical judgment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Required input
DICOM brain MRI with specified 3D T1 and T2 FLAIR acquisitions and protocols; supported scanners and acquisition requirements define the cleared processing scope.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Output and human action
Segmented color overlays, labels and volumes, age- and sex-matched reference percentiles, prior-study comparison, morphometric reports, and PACS/DICOM and PDF-style report outputs described in the submission.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Limitations
The product is adjunctive and requires professional review. Automated quality control and protocol checks do not remove the need to verify image quality, acquisition compatibility and clinical context.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

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
K251483
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Anatomy
Brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-09-23
  • 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
Processes DICOM brain MRI and returns segmented/quantitative results for PACS or report workflow; the exact site routing and viewer configuration require confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Deployment and data flow
Software processing service with automated QC and DICOM/PACS/report outputs; the public FDA summary does not establish the customer's hosting model.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

Current family release notes contain some controls, but exact K251483 security documentation, retention contract and assurance scope were not established.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

DICOM/PACS and report outputs

The cleared workflow returns segmented overlays, quantitative reports and DICOM/PACS-compatible results for professional review.

exact submission · checked 2026-09-07
Source

Institution-level longitudinal configuration

AIRS Medical's current SwiftSight-Brain release notes describe automatic prior-study detection, a longitudinal badge and service-engineer configuration.

product family · checked 2026-09-06

Current family release behavior is not asserted as the exact K251483 release.

Source

Family data-handling controls

Current SwiftSight-Brain release notes describe configurable retention/auto-purge, MFA and removal of patient names from processing history or generated reports.

product family · checked 2026-09-06

These statements do not establish a formal security certification or exact K251483 contract.

SourceSource

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 summary reports 3D T1 accuracy and reproducibility testing across scanners and countries, with Dice thresholds above 0.80 for major subcortical structures and above 0.75 for cortical structures and mean volume differences within 5%. T2 FLAIR testing reported lesion Dice above 0.80 and mean absolute lesion-volume difference below 0.25 cc.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

The cleared endpoints are segmentation, volume and reproducibility measures rather than disease-detection sensitivity.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

The cleared endpoints are segmentation, volume and reproducibility measures rather than disease-detection specificity.

3D T1 major subcortical Dice threshold

0.8 Dice coefficient, minimum reported threshold

  • EndpointSegmentation overlap
  • Population72-case 3D T1 accuracy and reproducibility evaluation across Philips, Siemens and GE scanners
  • Tested versionSS25-BR-CL configuration submitted in K251483
Source

3D T1 cortical Dice threshold

0.75 Dice coefficient, minimum reported threshold

  • EndpointSegmentation overlap
  • Population72-case 3D T1 accuracy and reproducibility evaluation across Philips, Siemens and GE scanners
  • Tested versionSS25-BR-CL configuration submitted in K251483
Source

3D T1 mean volume-difference threshold

5 percent absolute difference, maximum reported threshold

  • EndpointMean volume difference
  • Population72-case 3D T1 accuracy and reproducibility evaluation
  • Tested versionSS25-BR-CL configuration submitted in K251483
Source

T2 FLAIR lesion Dice threshold

0.8 Dice coefficient, minimum reported threshold

  • EndpointLesion segmentation overlap
  • Population160-case T2 FLAIR accuracy evaluation and 85-case reproducibility evaluation
  • Tested versionSS25-BR-CL configuration submitted in K251483
Source

T2 FLAIR mean absolute lesion-volume threshold

0.25 cc, maximum reported threshold

  • EndpointMean absolute lesion-volume difference
  • Population160-case T2 FLAIR accuracy evaluation
  • Tested versionSS25-BR-CL configuration submitted in K251483
Source

SwiftSight-Brain 3D T1 accuracy and reproducibility

  • DesignAccuracy and reproducibility evaluation across scanner manufacturers, field strengths, countries and adult age decades
  • Population3D T1 brain MRI: 72 accuracy/reproducibility cases; scanner subsets included Philips 54, Siemens 53 and GE 37 across the reported evaluations
  • Scopeexact submission
  • Tested versionSS25-BR-CL configuration submitted in K251483
  • Samplen=72
  • IndependenceSponsor or vendor study

K251483

FDA reports Dice >0.80 for major subcortical and >0.75 for cortical structures and mean volume differences <=5%.

Source

SwiftSight-Brain T2 FLAIR lesion accuracy and reproducibility

  • DesignAccuracy and reproducibility evaluation for brain lesion segmentation and volume
  • PopulationT2 FLAIR brain MRI with 160 accuracy cases and 85 reproducibility cases across vendors and countries
  • Scopeexact submission
  • Tested versionSS25-BR-CL configuration submitted in K251483
  • Samplen=160
  • IndependenceSponsor or vendor study

K251483

FDA reports lesion Dice >0.80 and mean absolute lesion-volume difference <0.25 cc.

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 2026-09-07

No public price or quote for SS25-BR-CL was reviewed.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-07

Payer policy research was not part of this worker's scope.

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 2026-09-07

The downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.

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
2026-09-07Last searched
22Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

Stored candidate metadata was screened; no PubMed or trial IDs were returned for this submission. This is not a full-paper review. 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, vendor faq, vendor release note, stored candidate metadata, 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 510(k) K251483: SwiftSight-Brain

    U.S. Food and Drug Administration - Accessed 2026-09-07

    Scope: identity, purpose, clinicalUse, modality, anatomy, workflowRole, intendedUsers, careSetting, input, output, limitations, integration, deployment, evidenceMetrics, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. SwiftSight-Brain model card (K251483)

    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. AIRS Medical FAQ: SwiftMR & SwiftSight Questions

    AIRS Medical - Accessed 2026-09-06

    Scope: productFamilyContext, clinicalUse, implementationCapabilities

  8. SS25-BR-CL v1.0.1.0

    AIRS Medical - Accessed 2026-09-06

    Scope: implementationCapabilities, security

  9. SS25-BR-CL v1.0.4.0

    AIRS Medical - Accessed 2026-09-06

    Scope: implementationCapabilities, security

Research history

  1. K251483 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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