K231669
- 510(k) number
- K231669
- Device name
- Ziehm Solo FD
- Applicant
- Ziehm Imaging GmbH DE
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2023-12-12
- Date received
- 2023-06-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K231669.pdf
Official FDA record: K231669
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.