K230949
- 510(k) number
- K230949
- Device name
- ARTIS pheno (VE30A)
- Applicant
- Siemens Medical Solutions USA, Inc. PA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2023-12-15
- Date received
- 2023-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K230949.pdf
Official FDA record: K230949
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.