K251901
- 510(k) number
- K251901
- Device name
- Magnifico Open (100009900)
- Applicant
- Esaote, S.p.A. IT
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-03-05
- Date received
- 2025-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K251901.pdf
Official FDA record: K251901
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.