K251059
- 510(k) number
- K251059
- Device name
- Syngo Carbon Clinicals (VA41)
- Applicant
- Siemens Healthineers AG DE
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-10-24
- Date received
- 2025-04-04
- 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: K251059.pdf
Official FDA record: K251059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.