K241295
- 510(k) number
- K241295
- Device name
- SOMATOM On.site
- Applicant
- Siemens Medical Solutions USA, Inc. TN · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-09-03
- Date received
- 2024-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241295.pdf
Official FDA record: K241295
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.