K251792
- 510(k) number
- K251792
- Device name
- Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
- Applicant
- Stereotaxis, Inc. MO · US
- Product code
- DXX — System, Catheter Control, Steerable
- Decision date
- 2025-11-06
- Date received
- 2025-06-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251792.pdf
Official FDA record: K251792
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.