K253023
- 510(k) number
- K253023
- Device name
- BIOGRAPH One
- Applicant
- Siemens Healthineers AG DE
- Product code
- OUO — Tomographic Imager Combining Emission Computed Tomog
- Decision date
- 2026-01-15
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253023.pdf
Official FDA record: K253023
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.