K243303
- 510(k) number
- K243303
- Device name
- Ziehm Vision RFD 3D
- Applicant
- Ziehm Imaging GmbH DE
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-01-21
- Date received
- 2024-10-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243303.pdf
Official FDA record: K243303
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.