K260852
- 510(k) number
- K260852
- Device name
- MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
- Applicant
- Siemens Healthineers AG DE
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-07-31
- Date received
- 2026-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K260852.pdf
Official FDA record: K260852
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.