K240099
- 510(k) number
- K240099
- Device name
- Ziehm Vision RFD
- Applicant
- Ziehm Imaging GmbH DE
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2024-02-05
- Date received
- 2024-01-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240099.pdf
Official FDA record: K240099
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.