K232206
- 510(k) number
- K232206
- Device name
- SOMATOM Pro.Pulse
- Applicant
- Siemens Medical Solutions USA, Inc. TN · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2023-12-06
- Date received
- 2023-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K232206.pdf
Official FDA record: K232206
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.