K260265
- 510(k) number
- K260265
- Device name
- MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
- Applicant
- Siemens Shenzhen Magnetic Resonance , Ltd. CN
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2026-02-23
- Date received
- 2026-01-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260265.pdf
Official FDA record: K260265
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.