GenesisX RMN— 510(k) K262744

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K262744 for GenesisX RMN, Substantially Equivalent on 2026-08-27. Applicant: Stereotaxis, Inc.. Device class: 2.

Clearance details

Applicant
Stereotaxis, Inc.
Product code
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
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