K241133
- 510(k) number
- K241133
- Device name
- Magnifico Open (100009900); Magnifico MSK ( 100009910)
- Applicant
- Esaote, S.p.A. IT
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2024-06-26
- Date received
- 2024-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K241133.pdf
Official FDA record: K241133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.