FDA.reportPublic FDA data

Cardiac mapping system application software

Definition
An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.
GUDID devices
96
Last updated
2026-06-11 06:05:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05415067055811EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-6.12026-06-01
00085142400710VIVO Positioning PatchesCatheter Precision, Inc.92082026-02-03
00851424007089VIVOCatheter Precision, Inc.90022026-02-03
00851424007119VIVO SystemCatheter Precision, Inc.90022026-02-03
05415067055613EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-062026-01-08
05415067054883EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-3.1.22025-12-19
05415067053435EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-052025-12-17
05415067054982EnSite™ST. JUDE MEDICAL, INC.ENSITE-ECHO-012025-12-17
05415067054999EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-ECHO-012025-12-17
05415067055217EnSite™ST. JUDE MEDICAL, INC.ENSITE-VM-CBL2025-12-17
05415067055224EnSite™ST. JUDE MEDICAL, INC.ENSITE-DUALMON-012025-12-17
05415067055231EnSite™ST. JUDE MEDICAL, INC.ENSITE-ECHO-VMCBL2025-12-17
05415067055248EnSite™ST. JUDE MEDICAL, INC.ENSITE-ECHO-VMMCBL2025-12-17
05415067051219EnSite™ST. JUDE MEDICAL, INC.ENSITE-VOLT-012025-12-08
05415067051288EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-VOLT-012025-12-08
05415067051158EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-AMI-012025-09-15
05415067051172EnSite™ST. JUDE MEDICAL, INC.ENSITE-AMI-012025-09-15
05415067053114EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-4.0.12025-09-05
05415067053343EnSite™ST. JUDE MEDICAL, INC.ENSITE-OTAC-032025-09-04
05415067051233NAST. JUDE MEDICAL, INC.ENSITE-ADAS-012025-08-15
05415067051264NAST. JUDE MEDICAL, INC.ENSITE-ADASLA-012025-08-15
05415067051295NAST. JUDE MEDICAL, INC.ENSITE-D-ADASLV-012025-08-15
05415067051301NAST. JUDE MEDICAL, INC.ENSITE-ADASLV-012025-08-15
05415067051318NAST. JUDE MEDICAL, INC.ENSITE-D-ADASLA-012025-08-15
05061038730050Mycardium MYCARDIUM AI LIMITED01.01.00(USA)2025-07-11
05415067053121EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-3.1.12025-04-03
05415067053138EnSite™ST. JUDE MEDICAL, INC.ENSITE-FWV-032025-04-03
05415067053145EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-FWV-032025-04-03
05415067049704EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-3.12024-08-14
05415067049711EnSite™ST. JUDE MEDICAL, INC.ENSITE-TFM-3.12024-08-14
05415067049988EnSite™ST. JUDE MEDICAL, INC.ENSITE-OTAC-022024-08-14
05415067051097EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-FWV-022024-08-14
05415067051103EnSite™ST. JUDE MEDICAL, INC.ENSITE-HDGX-012024-08-14
05415067051110EnSite™ST. JUDE MEDICAL, INC.ENSITE-FWV-022024-08-14
05415067050014EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-3.0.22024-03-27
05415067050021EnSite™ST. JUDE MEDICAL, INC.ENSITE-TFM-3.0.22024-03-27
05415067050281EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-FWV-012024-03-27
05415067050298EnSite™ST. JUDE MEDICAL, INC.ENSITE-FWV-012024-03-27
00850044849024Vivio System AppVentric HealthVA 1.02023-11-22
05415067047854EnSite™ST. JUDE MEDICAL, INC.ENSITE-SW-032023-08-16
05415067047861EnSite™ST. JUDE MEDICAL, INC.ENSITE-TFM-032023-08-16
05415067048332EnSite™ST. JUDE MEDICAL, INC.ENSITE-AMD-012023-08-16
05415067048349EnSite™ST. JUDE MEDICAL, INC.ENSITE-LS-012023-08-16
05415067048356EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-FLEX-012023-08-16
05415067048363EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-AMD-012023-08-16
05415067048370EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-IMP-012023-08-16
05415067048387EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-LS-012023-08-16
05415067048394EnSite™ST. JUDE MEDICAL, INC.ENSITE-FLEX-012023-08-16
05415067048400EnSite™ST. JUDE MEDICAL, INC.ENSITE-IMP-012023-08-16
00860009793507STAR ApolloRhythm AI Inc.STAR Apollo Mapping System2023-06-08
05415067046659EnSite™ST. JUDE MEDICAL, INC.ENSITE-TF-022023-02-15
05415067046673EnSite™ST. JUDE MEDICAL, INC.ENSITE-TFM-022023-02-15
05415067046802EnSite Precision™ST. JUDE MEDICAL, INC.H7040022022-10-25
05415067035004EnSite Precision™ST. JUDE MEDICAL, INC.H7027012022-06-03
05415067046185EnSite Precision™ST. JUDE MEDICAL, INC.H7040012022-06-03
00884838095229KODEX-EPD SystemPhilips Medical Systems Nederland B.V.7330152021-10-15
30680651480768HalyardO&M HALYARD, INC.480762021-01-20
05415067032249EnSite™ST. JUDE MEDICAL, INC.ENSITE-CF-012021-01-06
05415067032256EnSite™ST. JUDE MEDICAL, INC.ENSITE-D-CF-012021-01-06
05415067023230EnSite™ Velocity™ST. JUDE MEDICAL, INC.H7023232020-07-22
05415067033178EnSite Precision™ST. JUDE MEDICAL, INC.H7026022020-07-07
05415067033185EnSite™ST. JUDE MEDICAL, INC.H7026012020-07-07
05415067030092Advisor™ST. JUDE MEDICAL, INC.HD/VL Mapping Catheter2019-09-23
05415067031471Advisor™ST. JUDE MEDICAL, INC.VL Mapping Catheter, Sensor Enabled2019-09-23
B557ECHOINSIGHT0EchoInsightEPSILON IMAGING3.2.02019-03-12
05414734214636Ensite™ST. JUDE MEDICAL, INC.Fusion™ Module2015-12-04
05414734214841Ensite™ST. JUDE MEDICAL, INC.Fusion™ Module2015-12-04
05414734219211EnSite™ST. JUDE MEDICAL, INC.H219212016-04-21
05415067001856EnSite™ST. JUDE MEDICAL, INC.H7001852016-04-21
05415067001863EnSite™ST. JUDE MEDICAL, INC.H7001862016-04-21
05415067002921EnSite™ST. JUDE MEDICAL, INC.H7002922016-04-21
05415067002938EnSite™ST. JUDE MEDICAL, INC.H7002932016-04-21
05415067002952EnSite™ST. JUDE MEDICAL, INC.H7002952016-04-21
05415067003027EnSite™ST. JUDE MEDICAL, INC.1000371842016-05-24
05415067005861EnSite™ST. JUDE MEDICAL, INC.Derexi™2016-04-21
05415067023841MediGuide™ST. JUDE MEDICAL, INC.Technology2017-01-25
05415067024275MediGuide™ST. JUDE MEDICAL, INC.Technology2017-04-10
05415067026101EnSite™ Velocity™ST. JUDE MEDICAL, INC.H7024952016-12-08
05415067026118EnSite Precision™ST. JUDE MEDICAL, INC.H702496-T2016-12-20
05415067026125EnSite Precision™ST. JUDE MEDICAL, INC.H7024962016-12-20