K251030
- 510(k) number
- K251030
- Device name
- Sirona Advanced Imaging Suite
- Applicant
- Sirona Medical CA · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-10-22
- Date received
- 2025-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K251030.pdf
Official FDA record: K251030
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.