K243446
- 510(k) number
- K243446
- Device name
- 3DXR
- Applicant
- GE Medical Systems SCS FR
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2025-02-25
- Date received
- 2024-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243446.pdf
Official FDA record: K243446
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.