# Stereotaxis, Inc.

- Location (FDA's records): St. Louis, MO
- FDA decisions: 31 (2002–2026): 29 510(k) clearances and 2 original PMA approvals
- Product codes: DXX (9), DQX (8), PJB (3), DRF (2), DQY (2), DQK (2), NDQ (2), LPB (2), JAA (1)
- Predicates its devices cite: 43 (31 its own); citations of its devices by later devices: 38 (31 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baylis Medical Co., Inc.: 1 (https://510kreport.com/company/baylis-medical)
- Catheter Robotics, Inc.: 1 (https://510kreport.com/company/catheter-robotics)
- Catheter Research C/O Burditt, Bowles & Radzius: 1 (https://510kreport.com/company/catheter-research-c-o-burditt-bowles-radzius)
- Ge Dec Medical Systems: 1 (https://510kreport.com/company/ge-dec-medical-systems)
- Ep Technologies, Inc.: 1 (https://510kreport.com/company/ep-technologies)
- Brainlab AG: 1 (https://510kreport.com/company/brainlab)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Endosonics Corp.: 1 (https://510kreport.com/company/endosonics)

## Firms that cite its devices most
- Hansen Medical, Inc.: 1 (https://510kreport.com/company/hansen-medical)
- Mediguide, Ltd.: 1 (https://510kreport.com/company/mediguide)
- Sentreheart, Inc.: 1 (https://510kreport.com/company/sentreheart)
- Lake Region Mfg., Inc.: 1 (https://510kreport.com/company/lake-region-mfg)
- Biosense Webster, Inc.: 1 (https://510kreport.com/company/biosense-webster)
- Corindus, Inc.: 1 (https://510kreport.com/company/corindus)
- Catheter Robotics, Inc.: 1 (https://510kreport.com/company/catheter-robotics)

## Its most-cited devices
- K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath (2002), cited by 5
- K042854: Stereotaxis Endovascular Guide Wire (2005), cited by 4
- K060967: Niobe Magnetic Navigation System W/Navigant Workstation (2006), cited by 4
- K021555: Stereotaxis Niobe Magnetic Navigation System (2003), cited by 4
- K122659: Vdrive W/V-Sono (2013), cited by 3
- K071029: Cardiodrive Catheter Advancement System (Cas) (2007), cited by 3

## Recent decisions
- K262744: GenesisX RMN (Aug 27, 2026)
- K253473: Synchrony (Apr 1, 2026)
- P240014: MAGiC Ablation Catheter (Jan 5, 2026)
- K251792: Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (Nov 6, 2025)
- K250590: MAGiC Sweep™ EP Mapping Catheter (Jul 23, 2025)
- K193147: Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System (Mar 5, 2020)
- K192775: Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri (Oct 30, 2019)
- K183027: Steerable catheter control system (Sep 6, 2019)

Source page: https://510kreport.com/company/stereotaxis