Devices · Siemens Healthcare GmbH
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
Siemens Healthcare GmbH is listed for 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 (K252838). The FDA list gives December 19, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is LNH. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252838
- Date of final decision
- December 19, 2025
- Company on the FDA list
- Siemens Healthcare GmbH
- Lead panel
- Radiology
- Primary product code
- LNH
- openFDA device name for the code
- System, Nuclear Magnetic Resonance Imaging
- Device class
- 2
- Regulation number
- 892.1000
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary