K243523
- 510(k) number
- K243523
- Device name
- NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
- Applicant
- Siemens Medical Solutions USA, Inc. TN · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-02-12
- Date received
- 2024-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243523.pdf
Official FDA record: K243523
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.