K262744
- 510(k) number
- K262744
- Device name
- GenesisX RMN
- Applicant
- Stereotaxis, Inc. MO · US
- Product code
- DXX — System, Catheter Control, Steerable
- Decision date
- 2026-08-27
- Date received
- 2026-08-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K262744.pdf
Official FDA record: K262744
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.