K233657
- 510(k) number
- K233657
- Device name
- NAEOTOM Alpha
- Applicant
- Siemens Medical Solutions USA, Inc. TN · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2024-03-28
- Date received
- 2023-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K233657.pdf
Official FDA record: K233657
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.