Stereotaxis, Inc. - FDA 510(k) Cleared Devices

Cleared Aug 27, 2026

GenesisX RMN

K262744 · DXX

Cardiovascular · 24d

Cleared Apr 01, 2026

Synchrony

K253473 · DQK

Cardiovascular · 173d

Cleared Nov 06, 2025

Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)

K251792 · DXX

Cardiovascular · 148d

Cleared Jul 23, 2025

MAGiC Sweep™ EP Mapping Catheter

K250590 · DRF

Cardiovascular · 146d

Cleared Mar 05, 2020

Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System

K193147 · PJB

Cardiovascular · 113d

Cleared Oct 30, 2019

Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and...

K192775 · PJB

Cardiovascular · 30d

Cleared Sep 06, 2019

Steerable catheter control system

K183027 · PJB

Cardiovascular · 309d

Cleared Jun 17, 2015

Vdrive system, Vdrive Duo, Vdrive with V-Sono

K150312 · DXX

Cardiovascular · 128d

Cleared CT Dec 18, 2014

VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS

K141530 · DXX

Cardiovascular · 192d

Cleared CT Sep 03, 2014

VDRIVE WITH V-LOOP/ VDRIVE DUO

K140804 · DXX

Cardiovascular · 156d

Cleared Feb 06, 2014

VDRIVE WITH V-SONO

K133396 · DQX

Cardiovascular · 92d

Cleared Jul 26, 2013

VDRIVE W/V-SONO

K122659 · DQX

Cardiovascular · 329d