DICOM image return
Enhanced DICOM images transfer to PACS or MRI device.
exact submission · checked 2026-09-05FDA-cleared profile
SwiftMR
Airs Medical, Inc.
MRI image enhancement through noise reduction and sharpening; clinicians retain responsibility for final patient management decisions.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
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.
- Intended users
- Healthcare professionals, including radiology technologists in imaging centers, clinics and hospitals.
- Care setting and population
- Adult and pediatric imaging in healthcare facilities.
- Workflow role
- Post-processing image enhancement
- 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.
- 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.
- 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.
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.
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.
- Deployment and data flow
- The current vendor FAQ describes a gateway PC connected to MRI and PACS and discusses cloud deployment.
Current family documentation is not an exact-release hosting or data-processing agreement.
- Security and privacy
- Vendor documentation pending
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.
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.
This does not establish clinical drift surveillance or a contracted incident-response service.
Family implementation workflow
Gateway installation, MR-console protocol setup and user training are described by the vendor.
product family · checked 2026-09-05Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- 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.
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
An exact-release disease-detection sensitivity endpoint was not established in the reviewed enhancement validation.
- Reported specificity
- Not established in reviewed sources
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
Retrospective standalone image-quality and radiologist evaluation described in the FDA summary · Adult and pediatric MRI across neuro, musculoskeletal and body applications, scanner vendors, protocols and listed field strengths
exact submission · Tested version: SwiftMR configuration submitted in K253775 · Sponsor or vendor studyK253775
Includes standard and reduced-acquisition images. No clinical-outcome benefit is inferred from image-quality acceptance criteria.
Leveraging a vendor-neutral deep learning reconstruction algorithm to reduce scan time and enhance image quality in T2-weighted liver MRI
Retrospective single-center image-quality comparison with two radiologist readers · 86 patients undergoing nonenhanced 3 T liver MRI at Severance Hospital in August 2024
product family · Tested version: SwiftMR; exact software release not established in the reviewed abstract · n=86 · 1 site · Independence not establishedPMID: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.
Signal-to-noise ratio improvement in postmortem MRI using deep learning reconstruction (SwiftMR)
Postmortem head MRI comparison with blinded observer SNR measurements · 33 consecutive postmortem head examinations at 0.3 T
product family · Tested version: SwiftMR 3.0.11.0 · n=33 · Independence not establishedPMID:42019274 · DOI:10.1016/j.forsciint.2026.112973
Different software release and forensic population; not evidence of version 4 performance in living patients.
Economics and lifecycle
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
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
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
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
- Verify security and privacy controls: The family FAQ contains data-handling statements, but scoped dated assurance, contractual retention and exact-release security documentation remain unverified.
- Verify pricing and total cost: Reviewed vendor material offers a demo and ROI examples, not a price for the K253775 configuration. A license and implementation quote is needed.
- Verify reimbursement and coding relevance: No applicable payer coverage or payment policy was reviewed; vendor revenue examples are not reimbursement evidence.
- Verify recalls and postmarket safety signals: Downloaded exact-ID recall packet contained zero records; this limited result does not establish absence of recall or safety information.
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
3Reviewed PubMed leads
0Reviewed 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
Source ledger
Sources accessed through 2026-09-05.
- SwiftMR: K253775 clearance and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- SwiftMR model card (K253775) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
- 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 · 2026-09-04
- Signal-to-noise ratio improvement in postmortem MRI using deep learning reconstruction (SwiftMR). U.S. National Library of Medicine · 2026-09-04
- SwiftMR product and implementation FAQ AIRS Medical · 2026-09-05
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