K250443
- 510(k) number
- K250443
- Device name
- MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile
- Applicant
- Siemens Healthcare GmbH DE
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-06-16
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250443.pdf
Official FDA record: K250443
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.