K250822
- 510(k) number
- K250822
- Device name
- SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse
- Applicant
- Siemens Medical Solutions USA, Inc. TN · US
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2025-07-03
- Date received
- 2025-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.7 MB · U.S. public domain
Also available from FDA: K250822.pdf
Official FDA record: K250822
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.