Computer, Diagnostic, Programmable

Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic System Exercise Stress Testing ECG application

Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End

Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use.

Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac

CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides in

Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any a

McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management

iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System

CardioLab/ComboLab Recording Systems

MAC VU360, Model Number 2030360-001, Electrocardiograph

McKesson Cardiology Hemo

Horizon Cardiology Hemo

Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2.

Sensis Vibe System, Model Number 11007642, with software version VD10B.

Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081

Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monito

GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for u

VidiStar(TM) PACS & DICOM Viewer Software system

GE Healthcare CARESCAPE Monitor B650

McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitorin

GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physio

Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1

Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,

Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a

CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during el

AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology stu

Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheteriza

Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.

CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-ba

Merge HEMO software.

SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing

Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data.

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure

The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterizati

Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

Merge Hemo, 9.10, 9.20.0, 9.20.1,9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and r

The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1

Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnosti

McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patient

Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial

Philips IntelliSpace ECG Management System, with software option C61 needed to import ECGs from the Quinton Stress ECG System. Model No. 860426

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of

Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. Used for installing ICS G2 Clinical Access software onto hospital personal computers.

CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED

GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 20

20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.