Atlas FDA

DXX

33 FDA 510(k) clearances · Product code

128 daysmedian time to decision
283 days90th percentile
33clearances measured

FDA profile

Official device name
System, Catheter Control, Steerable
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1290
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 2011: 6 · 2014: 14 · 2016: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) (K251792)Stereotaxis, Inc.2025-11-06
LIBERTY Endovascular Robotic System (LIBERTYOS) (K243789)Microbot Medical , Ltd.2025-09-04
CorPath GRX System (K221464)Corindus, Inc.2022-07-27
CorPath GRX System (K202275)Corindus, Inc.2020-12-11
CorPath GRX System (K180517)Corindus, Inc.2018-03-29
CorPath GRX System (K173806)Corindus, Inc.2018-03-01
CorPath GRX System (K173288)Corindus, Inc.2018-02-15
CorPath GRX System (K160121)Corindus, Inc.2016-10-27
CorPath 200 System (K152999)Corindus, Inc.2016-03-18
CorPath 200 System (K150892)Corindus, Inc.2015-10-02
Magellan Robotic System (K151730)Hansen Medical, Inc.2015-07-23
Magellan Robotic System, Magellan Robotic Catheter 10Fr (K143227)Hansen Medical, Inc.2015-07-01
Vdrive system, Vdrive Duo, Vdrive with V-Sono (K150312)Stereotaxis, Inc.2015-06-17
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS (K141530)Stereotaxis, Inc.2014-12-18
VDRIVE WITH V-LOOP/ VDRIVE DUO (K140804)Stereotaxis, Inc.2014-09-03
MAGELLAN ROBOTIC SYSTEM (K141614)Hansen Medical2014-08-07
SENSEI X ROBOTIC CATHETER SYSTEM (K141822)Hanson Medical, Inc.2014-08-05
MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR (K132369)Hansen Medical, Inc.2013-09-27
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES (K122488)Catheter Robotics, Inc.2012-11-20
CORPATH 200 SYSTEM (K120834)Corindus, Inc.2012-07-19
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES (K113628)Catheter Robotics, Inc.2012-06-12
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER (K111004)Hansen Medical, Inc.2012-05-29
SENSEI X ROBOTIC CATHETER SYSTEM (K102168)Hansen Medical, Inc.2010-10-22
SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 (K091808)Hansen Medical, Inc.2009-09-10
HANSEN MEDICAL ARTISAN S CONTROL CATHETER (K090365)Hansen Medical, Inc.2009-05-07
SENSEI CATHETER CONTROL SYSTEM (K073225)Hansen Medical, Inc.2008-06-30
ODYSSEY WORKSTATION (K072371)Stereotaxis, Inc.2007-11-14
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH (K052480)Hansen Medical, Inc.2007-05-02
NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 (K051760)Stereotaxis, Inc.2006-05-05
NAVIGANT MAGNETIC NAVIGATION WORKSTATION 2.1 (NWS2) MODEL, 020-004500 (K032937)Stereotaxis, Inc.2004-07-01
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM (K021555)Stereotaxis, Inc.2003-01-15
CRI ELECTRONIC CONTROL SYSTEM (K924125)Catheter Research C/O Burditt, Bowles & Radzius1993-05-26
CRI STEERABLE CATHETER CONTROL SYSTEM (K904787)Catheter Research C/O Burditt, Bowles & Radzius1990-12-17

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Every clearance here is in the API, with alerts when new ones post.