FDA.reportPublic FDA data

510(k) K251792

Device
Stereotaxis GenesisX RMN with Navigant ? Workstation (NWS)
Applicant
Stereotaxis, Inc.
510(k) number
K251792
Product code
DXX
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-06
Date received
2025-06-11
Regulation
870.1290
Classification name
System, Catheter Control, Steerable
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Angela McKnight
Address
710 Tucker Blvd. Suite 110 Saint Louis MO US 63101 63101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.2025-09-04
K221464CorPath GRX SystemCorindus, Inc.2022-07-27
K202275CorPath GRX SystemCorindus, Inc.2020-12-11
K180517CorPath GRX SystemCorindus, Inc.2018-03-29
K173806CorPath GRX SystemCorindus, Inc.2018-03-01
K173288CorPath GRX SystemCorindus, Inc.2018-02-15
K160121CorPath GRX SystemCorindus, Inc.2016-10-27
K152999CorPath 200 SystemCorindus, Inc.2016-03-18
K150892CorPath 200 SystemCorindus, Inc.2015-10-02
K151730Magellan Robotic SystemHansen Medical, Inc.2015-07-23
K143227Magellan Robotic System, Magellan Robotic Catheter 10FrHansen Medical, Inc.2015-07-01
K150312Vdrive system, Vdrive Duo, Vdrive with V-SonoStereotaxis, Inc.2015-06-17
K141530VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CASStereotaxis, Inc.2014-12-18
K140804VDRIVE WITH V-LOOP/ VDRIVE DUOStereotaxis, Inc.2014-09-03
K141614MAGELLAN ROBOTIC SYSTEMHansen Medical2014-08-07