K251792 is an FDA 510(k) clearance for the Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS). This device is classified as a System, Catheter Control, Steerable (Class II - Special Controls, product code DXX).
Submitted by Stereotaxis, Inc. (Saint Louis, US). The FDA issued a Cleared decision on November 6, 2025, 148 days after receiving the submission on June 11, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1290.
| 510(k) Number | K251792 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2025 |
| Decision Date | November 06, 2025 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXX — System, Catheter Control, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1290 |