Globe Positioning System (GPS™) Electrodes
The FDA identifies Globe Positioning System (GPS) Electrodes as surface electrodes and cables for localizing the mapping catheter. They are accessories in a system that supports cardiac…
Pure EP – ECG Cable
The ECG Cable is an accessory to the PURE EP™ System. The ECG cable Assembly (4.8m) connects to standard ECG patches on the patient’s skin. The cable connects directly to the blue plug on…
Pure EP – 5 X 4 Pin Yoked Jumper Cable Red
5 cables in one bag with 4 pin yoked jumper cables red to split ECG signals between two ECG devices is an accessory to the PURE EP System. The PURE EP™ is a system that consists of two main…
Aluminium Carrying Case
Catalogue number 08ACC01, listed by CardioTek B.V., under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Affera™ Integrated Mapping System
The Affera Integrated Mapping System supports catheter-based cardiac electrophysiological mapping and stimulation. It displays the location of compatible catheters in real time and presents…
AT-Report
AT-Report is a medical device software that receives data stored in AT-Patch device using a Dedicated USB Cable and analyses it to provide information which is used to take decisions with…
Iecg
"Provides for the acquisition, processing, storage, and distribution for resting ECGs from Philips PageWriter cardiographs, IntelliVue Monitoring Systems, and Telemedicine Systems as well…
Navik 3d
Navik 3D™ is a multi-component computer system that utilizes image processing methods to provide three-dimensional (3D) location of catheters in real-time from acquired two-dimensional (2D)…
Pure EP – 5 X 10 Pin Yoked Jumper Cable Blue
5 cables in one bag with 10 pin yoked jumper cables blue to split ECG signals between two ECG devices is an accessory to the PURE EP System The PURE EP™ is a system that consists of two…
Premier Heart MCG Analysis Software
Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
CardioDay V2.5
The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, analysis, edit, review, report, and storage of ambulatory and multi-parameter ECG data. Results of the automated…
Swan-Ganz
Patient CCO cable - HemoSphere Alta advanced monitoring platform
Holter ECG and ABP System
The Holter ECG and ABP System reviews ambulatory ECG and blood-pressure recordings captured by compatible recorders. It is Windows-based software for retrospective analysis, editing,…
CoroFlow
Catalogue number 12000, listed by Coroventis Research AB, Sweden, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Premier Heart MCG Model VH12
Premier Heart MCG 12 Lead capture hardware.
Adapter Cables Unipolar/ Bipolar (Set of 10)
Catalogue number 03UBC02, listed by CardioTek B.V., under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
12 Pneumatic Endo Probes for Endo PAT 2000
12 Pneumatic Endo probes
Premier Heart MCG Analysis API
MCG Analysis API (Dedicated Server or Software-as-a-Service)
Guidewire
Catalogue number SGW-011-08, listed by Galt Medical Corp., United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
McKesson Cardiology ECG Management
2 catalogue numbers from 14.0, listed by Change Healthcare Canada Company, Canada, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
NorthStar Mapping System
Catalogue number MAP01-01, listed by Imricor Medical Systems, United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Acumen IQ Fluid Meter
Catalogue number AIQFM, listed by Edwards Lifesciences Technology Sarl, United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
HealthView ECG Manager
The HealthView ECG Manager is a computer system, used within a clinical network, which is intended to be used by trained professionals. It provides the ability to retrieve, store, edit,…
Vektor Medical Vmap Software
Catalogue number vMap Software - US, listed by Vektor Medical, Inc., United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
RhythmAnalytics
Catalogue number 1.1, listed by Biofourmis Singapore Pte., Ltd., Singapore, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Iecg
"Provides for the acquisition, processing, storage, and distribution for resting ECGs from Philips PageWriter cardiographs, IntelliVue Monitoring Systems, and Telemedicine Systems as well…
Cordiana Dx16
Cordiana Dx16 is browser-based software for viewing, manually editing and printing cardiopulmonary studies and their associated reports. Trained healthcare professionals use it in…
Affera™ Mapping System
The Affera Mapping System displays the position of compatible cardiac catheters and creates maps for electrophysiology procedures. It can record and display patient signals, including…
OptiMap™ System – NA
The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias.
Sensis Vibe Combo
Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22
Pure EP – 5 X Single Jumper Cable Red 0.3m
5 cables in one bag with single jumper cables red to split ECG signals between two ECG devices is an accessory to the PURE EP System The PURE EP™ is a system that consists of two main…
Acumen IQ Plus
The Acumen IQ Plus Finger Cuff is a component for continuous, noninvasive measurement of blood pressure and related hemodynamic parameters. Model AIQCA2 is used with a compatible Edwards…
Sensis Lite
Catalogue number 10764562, listed by Siemens Healthcare Limited, Canada, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Pathfinder SL, SENTINEL10
Upgrade: PA-Digital TO Pathfinder SL, SENTINEL10
Volta AF-Xplorer II
Catalogue number A003, listed by Substrate HD, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Cardio Server
Web-Enabled, Server-Based, Multi-Modality Database supporting the enterprise with up to 250 concurrent users. Includes- Secure access, digital signature, critical alert logs, HIPAA logs,…
CoroFlow PPG Software
Software upgrade for CoroFlow Cardiovascular System
Medilog DARWIN2 U
The medilog® DARWIN2 U Holter Analysis is intended for the replay and analysis of ECG data pre-recorded on medilog series ambulatory recorders.
Globe® Workstation
Catalogue number 601-00064, listed by Kardium Inc., Canada, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
CoroFlow Cardiovascular System
CoroFlow Cardiovascular System is a system used to collect, calculate, present and store physiological parameters measured by Abbott Medical’s PressureWire X and Wi-box. Parameters include…
Advisor™ FL Mapping Catheter, Sensor Enabled™
Software Installation
Change Healthcare Cardiology ECG Mobile
2 catalogue numbers from 1.2.4, listed by Change Healthcare Israel Ltd., Israel, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Iops™ Software Application
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for…
Nuubo System
Nuubo Leonardo Box USA. Software for downloading, analysis, visualization and report of the ECG-data stored by the recorder device and for managing the recorder device.
Clab II Plus Amplifier
Assy Clabii PLUS128 AMP 110-240V 50/60HZ, AM 1
Stealth System S300
StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300).
OptiMap Cart
Catalogue number FG0010, listed by Cortex, Inc., United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
DeepRhythmAI
DeepRhythmAI assesses cardiac arrhythmias using single- or two-lead ECG data from adult patients. The software is designed for integration into web, mobile or other applications so…
ILR ECG Analyzer
Catalogue number V1.1.4, listed by Implicity, France, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Pyramis
2 catalogue numbers from 11095-002-61, listed by Mortara Instrument, Inc., United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Kodex-EPD System
KODEX-EPD is a cardiac mapping system used during catheter based electrophysiology procedures. It provides information about heart electrical activity and catheter location for patients…
Pure EP – 5 X 10 Pin Yoked Jumper Cable Green
5 cables in one bag with 10 pin yoked jumper cables green to split ECG signals between two ECG devices is an accessory to the PURE EP System. The PURE EP™ is a system that consists of two…
Imap 3d Mapping and Navigation System
iMap is a three-dimensional cardiac mapping and catheter-navigation system for conventional electrophysiology procedures. It displays compatible catheter positions, electrical waveforms and…
CoroFlow Upgrade Kit
Software upgrade for Coroventis CoroFlow System
OptiMap Monitor
Catalogue number FG0009, listed by Cortex, Inc., United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
McKesson Cardiology Hemo
Catalogue number 13.2.1, listed by Change Healthcare Canada Company, Canada, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Acumen IQ
Acumen IQ Sensor 60'' / 152CM With Fluid Meter With Vamp 5-PACK
Iops Visionary System
IOPS Visionary evaluates vascular anatomy using 3D models from previously acquired scan data and supports real-time positioning and navigation of compatible sensor-equipped catheters and…
Synecom
Catalogue number V3.10, listed by Microport CRM SRL, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Pure EP – 5 X 10 Pin Yoked Jumper Cable White
5 cables in one bag with 10 pin yoked jumper cables yellow to split ECG signals between two ECG devices is an accessory to the PURE EP System. The PURE EP™ is a system that consists of two…
Pure EP – Catheter Input Module
The Catheter Input Module - IC1 J-Box Unipolar/Bipolar Cable Assembly (3m) is an accessory to the PURE EP™ System. The catheter input modules are used for connecting the IC catheters to the…
TactiCath™ Ablation Catheter, Sensor Enabled™
Catheter Catalog Installation
Globe Positioning System (GPS™) Cable
Catalogue number 601-00036, listed by Kardium Inc., Canada, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Philips
Catalogue number 860343, listed by Philips Medical Systems Hsg, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.
Holter Prep Kit
Holter prep kit with AA battery cleared with Vision 5LR recorder
Vivo
The FDA filing describes VIVO Model 9002 software as creating, displaying, and storing a cardiac activation map that displays the earliest activation site of ventricular arrhythmias. The…
Avvigo™ Guidance System II
Catalogue number H749009881C0, listed by Boston Scientific Corporation, United States, under Computer, Diagnostic, Programmable. 10 manufacturers in China are registered for this product code.