510(k) clearance

GenesisX RMN

FDA 510(k) source

510(k) number

K262744

Applicant

Stereotaxis, Inc.

Decision date

Aug 27, 2026

Date received

Aug 3, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

DXX

Device type

System, Catheter Control, Steerable

Device class

Class II

Regulation

21 CFR 870.1290

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

N

Location

St. Louis, MO, US