K234109
- 510(k) number
- K234109
- Device name
- Ziehm Solo FD
- Applicant
- Ziehm Imaging GmbH DE
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-01-26
- Date received
- 2023-12-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K234109.pdf
Official FDA record: K234109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.