Cleared Traditional

Stereotaxis GenesisX RMN with Navigant ? Workstation (NWS)

K251792 · Stereotaxis, Inc. · Cardiovascular
Nov 2025
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K251792 is an FDA 510(k) clearance for the Stereotaxis GenesisX RMN with Navigant ? Workstation (NWS), 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 review panel. Regulated under 21 CFR 870.1290.

Submission Details

510(k) Number K251792 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code DXX — System, Catheter Control, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1290