K252838
- 510(k) number
- K252838
- Device name
- MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
- Applicant
- Siemens Healthcare GmbH DE
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-12-19
- Date received
- 2025-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K252838.pdf
Official FDA record: K252838
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.