Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
FDA 510(k) K251792 · Stereotaxis, Inc.
510(k) numberK251792
Submission
- Device name
- Stereotaxis GenesisX RMN with Navigant Workstation (NWS)
- Applicant
- Stereotaxis, Inc.
Saint Louis, MO, US - Received
- June 11, 2025
- Decision date
- November 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXX – System, Catheter Control, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1290
- Specialty
- Cardiovascular
Other 510(k)s with product code DXX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262744 | GenesisX RMNDXX · Special | Stereotaxis, Inc. | 08/27/2026SE |
| K243789 | LIBERTY Endovascular Robotic System (LIBERTYOS)DXX · Traditional | Microbot Medical , Ltd. | 09/04/2025SE |
| K221464 | CorPath GRX SystemDXX · Special | Corindus, Inc. | 07/27/2022SE |
| K202275 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 12/11/2020SE |
| K180517 | CorPath GRX SystemDXX · Special | Corindus, Inc. | 03/29/2018SE |
| K173806 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 03/01/2018SE |
| K173288 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 02/15/2018SE |
| K160121 | CorPath GRX SystemDXX · Traditional | Corindus, Inc. | 10/27/2016SE |
| K152999 | CorPath 200 SystemDXX · Traditional | Corindus, Inc. | 03/18/2016SE |
| K150892 | CorPath 200 SystemDXX · Traditional | Corindus, Inc. | 10/02/2015SE |
More from Corindus, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262744 | GenesisX RMNDXX · Special | 08/27/2026SE |
| K253473 | SynchronyDQK · Traditional | 04/01/2026SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | 07/23/2025SE |
| K193147 | Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemPJB · Traditional | 03/05/2020SE |
| K192775 | Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriPJB · Special | 10/30/2019SE |
| K183027 | Steerable catheter control systemPJB · Traditional | 09/06/2019SE |
| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-SonoDXX · Traditional | 06/17/2015SE |
| K141530 | Vdrive System/ Vdrive Duo/ Vdrive with V-CasDXX · Traditional | 12/18/2014SE |
| K140804 | Vdrive with V-Loop/ Vdrive DuoDXX · Traditional | 09/03/2014SE |
| K133396 | Vdrive with V-SonoDQX · Special | 02/06/2014SE |
Questions and answers
When was Stereotaxis GenesisX RMN with Navigant Workstation (NWS) cleared by the FDA?
Stereotaxis GenesisX RMN with Navigant Workstation (NWS) (K251792) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 148 days after the submission was received.
What is the product code of K251792?
The FDA product code is DXX – System, Catheter Control, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1290.