Radiology AI Directory

FDA-cleared profile

SwiftMR

Airs Medical, Inc.

Authorized purpose: MRI image enhancement through noise reduction and sharpening; clinicians retain responsibility for final patient management decisions.

MRI workflow
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: MRI image enhancement through noise reduction and sharpening; clinicians retain responsibility for final patient management decisions.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: MRI image enhancement through noise reduction and sharpening; clinicians retain responsibility for final patient management decisions.

Evidence takeaway

Evidence from the reviewed source record: K253775 describes retrospective standalone image-quality validation across adult and pediatric images, body regions, vendors and protocols. Published SwiftMR studies reviewed below are family context, not verified results for version 4.

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
MRI image enhancement through noise reduction and sharpening; clinicians retain responsibility for final patient management decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Healthcare professionals, including radiology technologists in imaging centers, clinics and hospitals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Adult and pediatric imaging in healthcare facilities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Workflow role
Post-processing image enhancement
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
DICOM MRI of all body parts at 0.25, 0.31, 0.4, 0.55, 0.6, 1.5 and 3.0 T, including images produced by conventional vendor reconstruction or vendor-implemented deep-learning reconstruction.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Enhanced DICOM MR images returned to PACS or the MRI device; adjustable denoising levels 0-8 and sharpness levels 0-5.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
An image-enhancement aid, not a substitute for clinician decisions; not intended for mobile devices. The listed field strengths define the cleared acquisition scope.
  • 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
K253775
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
MRI
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Whole Body
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-03-26
  • 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
Automatic background DICOM processing with a client for status and administrative settings; enhanced images transfer to PACS or the MRI device.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Deployment and data flow
The current vendor FAQ describes a gateway PC connected to MRI and PACS and discusses cloud deployment.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05

Current family documentation is not an exact-release hosting or data-processing agreement.

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

The family FAQ contains data-handling statements, but scoped dated assurance, contractual retention and exact-release security documentation remain unverified.

Training and support
The vendor describes gateway installation, protocol setup on the MR console, user training and monitoring during implementation.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05

The advertised implementation schedule is not a site-specific service commitment.

Monitoring and change control
The vendor describes ongoing monitoring of usage and user satisfaction.
  • Vendor supplied
  • Product family
  • Checked 2026-09-05

This does not establish clinical drift surveillance or a contracted incident-response service.

DICOM image return

Enhanced DICOM images transfer to PACS or MRI device.

exact submission · checked 2026-09-05
Source

Family implementation workflow

Gateway installation, MR-console protocol setup and user training are described by the vendor.

product family · checked 2026-09-05
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
K253775 describes retrospective standalone image-quality validation across adult and pediatric images, body regions, vendors and protocols. Published SwiftMR studies reviewed below are family context, not verified results for version 4.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Regulatory acceptance thresholds are not reported here as achieved average performance. The public summary does not give a single validation sample total.

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

An exact-release disease-detection sensitivity endpoint was not established in the reviewed enhancement validation.

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

An exact-release disease-detection specificity endpoint was not established in the reviewed enhancement validation.

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

K253775 standalone MRI enhancement validation

  • DesignRetrospective standalone image-quality and radiologist evaluation described in the FDA summary
  • PopulationAdult and pediatric MRI across neuro, musculoskeletal and body applications, scanner vendors, protocols and listed field strengths
  • Scopeexact submission
  • Tested versionSwiftMR configuration submitted in K253775
  • IndependenceSponsor or vendor study

K253775

Includes standard and reduced-acquisition images. No clinical-outcome benefit is inferred from image-quality acceptance criteria.

Source

Leveraging a vendor-neutral deep learning reconstruction algorithm to reduce scan time and enhance image quality in T2-weighted liver MRI

  • DesignRetrospective single-center image-quality comparison with two radiologist readers
  • Population86 patients undergoing nonenhanced 3 T liver MRI at Severance Hospital in August 2024
  • Scopeproduct family
  • Tested versionSwiftMR; exact software release not established in the reviewed abstract
  • Samplen=86
  • Sites1
  • IndependenceIndependence not established

PMID:42420358 · DOI:10.1038/s41598-026-60802-5

Compared routine two-breath-hold imaging with SwiftMR one- and two-breath-hold imaging. Improved sharpness/SNR did not eliminate the motion tradeoff; no K253775 linkage is asserted.

Source

Signal-to-noise ratio improvement in postmortem MRI using deep learning reconstruction (SwiftMR)

  • DesignPostmortem head MRI comparison with blinded observer SNR measurements
  • Population33 consecutive postmortem head examinations at 0.3 T
  • Scopeproduct family
  • Tested versionSwiftMR 3.0.11.0
  • Samplen=33
  • IndependenceIndependence not established

PMID:42019274 · DOI:10.1016/j.forsciint.2026.112973

Different software release and forensic population; not evidence of version 4 performance in living patients.

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 vendor material offers a demo and ROI examples, not a price for the K253775 configuration. A license and implementation quote is needed.

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

No applicable payer coverage or payment policy was reviewed; vendor revenue examples are not reimbursement evidence.

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 2026-09-06

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.

Human reviewedStatus
2026-09-05Last searched
19Fields reviewed
11Source classes checked
3Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

42420358 and 42019274 retained as family contextual studies after abstract review. 38893725 metadata is relevant to TWIST MRA enhancement, but the live PubMed page did not provide readable content and exact-release linkage remains unresolved; no results 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, acr ai central product, fda decision summary, vendor product page, peer reviewed literature, 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. SwiftMR: K253775 clearance and 510(k) summary

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

    Scope: purpose, clinicalUse, modality, anatomy, input, output, limitations, integration, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. SwiftMR model card (K253775)

    American College of Radiology - Published 2026-08-26 - Accessed 2026-09-01

    Scope: purpose, modality, 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. Leveraging a vendor-neutral deep learning reconstruction algorithm to reduce scan time and enhance image quality in T2-weighted liver MRI.

    U.S. National Library of Medicine - Accessed 2026-09-04

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  8. Signal-to-noise ratio improvement in postmortem MRI using deep learning reconstruction (SwiftMR).

    U.S. National Library of Medicine - Accessed 2026-09-04

    Scope: evidenceStudies, productFamilyContext, evidenceDiscovery

  9. SwiftMR product and implementation FAQ

    AIRS Medical - Accessed 2026-09-05

    Scope: productFamilyContext, deployment, training, monitoring, implementationCapabilities

Research history

  1. K253775 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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