K251561
- 510(k) number
- K251561
- Device name
- Biograph Trinion
- Applicant
- Siemens Medical Solutions USA, Inc. TN · US
- Product code
- KPS — System, Tomography, Computed, Emission
- Decision date
- 2025-07-31
- Date received
- 2025-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251561.pdf
Official FDA record: K251561
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.