FDA.reportPublic FDA data

Cardiac electrophysiology analysis system

Definition
An assembly of devices designed to perform several diagnostic tests and therapeutic treatments of the heart in patients with arrhythmic or conduction disorders. It typically consists of a computerized workstation including a monitor, a printer or graphic recorder, a data recorder (e.g., optical or magnetic disk), and plug-in modules for signal amplification and/or conditioning. Signals are taken from external electrodes on the chest as well as from intracardiac electrodes and from blood pressure transducers. Device uses include analysis of the atrioventricular conduction system, defibrillator function, and the induction/termination of ventricular tachycardia.
GUDID devices
45
Last updated
2026-09-04 23:11:01

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.AltiX XI2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.AltiX XI2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.AltiX XI2026-08-26
04260441452615EP-TRACERCardioTek B.V.60SYS012024-12-10
04260441452639EP-TRACERCardioTek B.V.60SYS032024-12-10
00195278931504MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.AltiX AI.i2025-05-05
00195278935656CardioLabGe Medical Systems Information Technologies, Inc.AltiX AI.i2025-05-05
00195278935687ComboLabGe Medical Systems Information Technologies, Inc.AltiX AI.i2025-05-05
00195278940193MLCL UpgradeGe Medical Systems Information Technologies, Inc.AltiX AI.i2025-05-05
00840682188968MLCL UpgradeGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.BT212020-06-12
04260441452622EP-TRACERCardioTek B.V.60SYS022024-11-18
05745001034009ECGenius SystemCathvision ApSCVT-0069 R3.22024-04-22
05700002168535ECGenius SystemCathvision ApSCVT-0069 R3.02023-08-16
05700002168528ECGenius SystemCathvision ApSCVT-0069 R2.02022-06-15
00195278507044CardioLabGe Medical Systems Information Technologies, Inc.AltiX2022-05-01
00195278516015MLCL UpgradeGe Medical Systems Information Technologies, Inc.AltiX2022-05-01
00856750007093Pure EP - 5 x Single Jumper Cable Red 0.3mBIOSIG TECHNOLOGIES, INC.PE-002-013-0052022-02-07
00856750007109Pure EP - 5 x Single Jumper Cable Black 0.3mBIOSIG TECHNOLOGIES, INC.PE-002-014-0052022-02-07
00856750007116Pure EP - 5 x Single Jumper Cable Black 0.1mBIOSIG TECHNOLOGIES, INC.PE-002-017-0052022-02-07
00856750007130Pure EP - 5 x 10 pin Yoked Jumper Cable WhiteBIOSIG TECHNOLOGIES, INC.PE-002-019-0052022-02-07
00856750007147Pure EP - 5 x 10 pin Yoked Jumper Cable BlueBIOSIG TECHNOLOGIES, INC.PE-002-020-0052022-02-07
00856750007154Pure EP - 5 x 10 pin Yoked Jumper Cable GreenBIOSIG TECHNOLOGIES, INC.PE-002-018-0052022-02-07
00856750007161Pure EP - 5 x 4 pin Yoked Jumper Cable YellowBIOSIG TECHNOLOGIES, INC.PE-002-015-0052022-02-07
00856750007178Pure EP - 5 x 4 pin Yoked Jumper Cable RedBIOSIG TECHNOLOGIES, INC.PE-002-016-0052022-02-07
00856750007031Pure EP - Catheter Input ModuleBIOSIG TECHNOLOGIES, INC.PE-002-006-0002021-06-30
00856750007048Pure EP - Catheter Input ModuleBIOSIG TECHNOLOGIES, INC.PE-002-007-0002021-06-30
00856750007055Pure EP - ECG Cable BIOSIG TECHNOLOGIES, INC.PE-002-008-0002021-06-30
00856750007123Pure EP - Dual ECG Splitter BoxBIOSIG TECHNOLOGIES, INC.PE-002-021-0002021-05-12
00856750007000Pure EPBIOSIG TECHNOLOGIES, INC.AE-0001-4122021-05-05
04260441455326EP-TRACERCardioTek B.V.32SYS022021-02-03
08567500070008Pure EPBIOSIG TECHNOLOGIES, INC.AE-0001-4122021-01-20
04260441455425EP-TRACERCardioTek B.V.40SYS022020-09-14
00840682119641CardioLabGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.Simulator2016-07-03
00840682119665PDM Base StationGE Medical Systems Information Technologies, Inc.Plus2016-07-03
04260441450482Adapter cables unipolar/ bipolar (set of 10)CardioTek B.V.03UBC022020-02-17
04260441450574Aluminium carrying caseCardioTek B.V.08ACC012020-01-30
04260441455418EP-TRACER CardioTek B.V.40SYS012020-01-20
00840682145985Mac-LabGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.A12019-06-11
00840682146012CardioLabGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.A12019-06-11
07290102932818EMS-XLMENNEN MEDICAL LTD.32 Ch. Lite System 2016-09-24
07290102932832EMS-XLMENNEN MEDICAL LTD.64 Ch. Lite System 2016-09-24
07290102933051EMS-XLMENNEN MEDICAL LTD.32 Ch. Mobile System 2016-09-24
07290102933068EMS-XLMENNEN MEDICAL LTD.32 Ch. Console System 2016-09-24
07290102933075EMS-XLMENNEN MEDICAL LTD.64 Ch. Mobile System2016-09-24
07290102933082EMS-XLMENNEN MEDICAL LTD.64 Ch. Console System2016-09-24