K253775
- 510(k) number
- K253775
- Device name
- SwiftMR
- Applicant
- Airs Medical, Inc. KR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-03-26
- Date received
- 2025-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253775.pdf
Official FDA record: K253775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.