GenesisX RMN— 510(k) K262744
Substantially EquivalentStereotaxis, Inc.
FDA 510(k) clearance K262744 for GenesisX RMN, Substantially Equivalent on 2026-08-27. Applicant: Stereotaxis, Inc.. Device class: 2.
Summary
Stereotaxis's GenesisX RMN is filed under product code DXX, steerable catheter control systems. The record doesn't expand RMN or describe the system further.
Class II, 21 CFR 870.1290. Cardiovascular is both the classification panel and the review panel. The submission type is Special 510(k).
Stereotaxis filed from St. Louis, Missouri. The decision came 24 calendar days after FDA received it (August 3 to August 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Stereotaxis, Inc.
- Product code
- Product code DXX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- St. Louis, MO, US
Recent devices under product code DXX
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