K230854
- 510(k) number
- K230854
- Device name
- SwiftMR
- Applicant
- Airs Medical, Inc. KR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-10-27
- Date received
- 2023-03-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230854.pdf
Official FDA record: K230854
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.