No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10841522127069 | 96102 | 96102 | XHIBIT CENTRAL STATION,96102 | MSX,DSI,MHX,MLD | System, network and communication, physiological monitors,DETECTOR AND ALARM, AR System, network and communication, physiological monitors,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM | 2 | Xhibit |
2 | 10841522124587 | 90207, 90207A, 90217, 90227,TARSAN | N/A | UNIVERSAL CUFF COVER LARGE SIZE - BOX OF 50 | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
3 | 10841522124570 | 90207, 90207A, 90217, 90227, TARSAN | 706-0182-00 | UNIVERSAL CUFF COVER STANDARD SIZE - BOX OF 50 | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
4 | 10841522123177 | 90227 | 90227-1 | ABP ONTRAK MONITOR, MULTI-LINGUAL | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
5 | 10841522122996 | 96501 | 96501 | 96501,XHIBIT XC4 | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Xhibit |
6 | 10841522122460 | CD12USB | CD12M | CARDIODIRECT12M | DPS | Electrocardiograph | 2 | CD12 |
7 | 10841522122453 | CD12USB | CD12MI | CARDIODIRECT12MI | DPS | Electrocardiograph | 2 | CD12 |
8 | 10841522122446 | CD12USB | CD12SENTINEL | CARDIODIRECT12, FOR SENTINEL | DPS | Electrocardiograph | 2 | CD12 |
9 | 10841522122439 | CD12US | CD12S | CARDIODIRECT12S | DPS | Electrocardiograph | 2 | CD12 |
10 | 10841522108341 | 90217 | N/A | 90217/90217A Ultralite ABP Monitor, Ambulatory Blood Pressure | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
11 | 10841522107832 | 96102 | L-96102 | CENTRAL STATION,96102,LOANER | MLD,DSI,MHX,MSX | MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOG MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS | 2 | Xhibit |
12 | 10841522107719 | 90227 | L-90227-1 | LOANER - ABP ONTRAK MONITOR, MULTI-LINGUAL | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
13 | 10841522107160 | 96102 | N/A | Central Station | DSI,MSX,MHX,MLD | DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MO DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM | 2 | Xhibit |
14 | 10841522106453 | 92506 | N/A | Ambulatory Blood Pressure (ABP) Report Management System | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
15 | 10841522106446 | 92506 | N/A | Ambulatory Blood Pressure (ABP) Report Management System | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
16 | 10841522105074 | 90217 | N/A | Ambulatory Blood Pressure Monitor | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
17 | 10841522105067 | 90217 | N/A | ABP ULTRALITE MONITOR,MULTI-LINGUAL | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | ABP |
18 | 10841522100536 | 96102 | 011-0241-01 | DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE | MSX,MHX | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS,MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Xhibit |
19 | 10841522100345 | 96102 | 96102 | XHIBIT CENTRAL STATION,96102 | MHX,MLD,DSI,MSX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS),MONITOR, ST SEGMENT WITH ALARM,DETECTOR AND ALARM, ARRHYTHMIA,SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS | 2 | Xhibit |
20 | 30841522123041 | ARIA; SUPPLY | 23189-106-401 | KIT,HOOK-UP,CASE OF 20,ARIA | DSH | RECORDER, MAGNETIC TAPE, MEDICAL | 2 | SPACELABS HEALTHCARE |
21 | 30841522122860 | TAY | 50-0191 | HOOK UP KIT WITH SINGLE USE POUCH, CASE OF 20 | DSH | RECORDER, MAGNETIC TAPE, MEDICAL | 2 | SPACELABS HEALTHCARE |
22 | 10841522129551 | 98201 | 040-1766-00 | UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER | DQK | Computer, diagnostic, programmable | 2 | Sentinel |
23 | 10841522129537 | 98000 | 98000SL | PATHFINDER SL ANALYSER | DQK | Computer, diagnostic, programmable | 2 | PATHFINDER |
24 | 10841522129414 | 98200 | 040-1725-01 | SENTINEL 11 RDT TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
25 | 10841522129315 | 98200 | 040-1748-01 | SENTINEL 11 / PATHFINDER SL KIT FR | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
26 | 10841522129308 | 98200 | 040-1724-01 | SENTINEL 11 HL7 TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
27 | 10841522129292 | 98200 | 040-1723-01 | SENTINEL 11 NETWORKED TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
28 | 10841522129285 | 98200 | 040-1722-01 | SENTINEL 11 STANDALONE TEST SYSTEM | DQK | Computer, diagnostic, programmable | 2 | SENTINEL |
29 | 10841522129070 | SUPPLY | 714-0018-00 | NIBP,HOSE ASSY,ADULT,QUICK RELEASE | DXN | System, measurement, blood-pressure, non-invasive | 2 | SPACELABS HEALTHCARE |
30 | 10841522129063 | 91436 | 91436F | FLEXPORT INTERFACE, PB840 VENTILATOR | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
31 | 10841522128752 | Supply | 685-0037-00 | PRE-WIRED NEO ELECTRODES SET,DIN,SPU,3/ST,100/BX | DSI | DETECTOR AND ALARM, ARRHYTHMIA | SPACELABS HEALTHCARE | |
32 | 10841522127359 | 91518; 92518 | 015-0313-01 | SAMPLE LINE,AGENT,W/SAMPLING TEE,10',50/BX | CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) | SPACELABS HEALTHCARE | |
33 | 10841522127342 | 91518; 92518 | 015-0312-01 | SAMPLE LINE,AGENT,W/SAMPLING TEE,7',50/BX | CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) | SPACELABS HEALTHCARE | |
34 | 10841522127052 | 90478 | 040-1429-04 | KIT, MULTI-BAND, WO/PS, PLEN, ACT ANT,ADC | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Ultraview |
35 | 10841522126864 | 90227 | 90227-2 | ABP ONTRAK MONITOR, GERMAN | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | SPACELABS HEALTHCARE |
36 | 10841522105463 | 90478 | MDTM, MV1, DL, ST, UHF | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Ultraview | |
37 | 10841522126857 | TARSAN | 90217A-2 | ABP ULTRALITE MONITOR, GERMAN | DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 2 | SPACELABS HEALTHCARE |
38 | 10841522126833 | 91496 | 700-0906-01 | CABLE,SPO2,MASIMO SET,LNCS | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
39 | 10841522126826 | 91496 | 700-0792-00 | CABLE,SPO2,NELLCOR,OXIMAX | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
40 | 10841522126819 | SUPPLY | 700-0002-00 | CABLE ASSY,SPO2,NELLCOR DFN SENSORS | DQA | Oximeter | 2 | SPACELABS HEALTHCARE |
41 | 10841522126444 | 91517 | 704-0003-00 | ACSRY,ADAPTER,AIRWAY,NEO,REUSE | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
42 | 10841522126437 | 91517 | 704-0002-00 | ACSRY,ADAPTER,AIRWAY,ADULT,REUSE | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
43 | 10841522126420 | 91517 | 704-0028 | CO2 SAMPLE LINE W/MALE LUER W/NAFION | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
44 | 10841522126406 | 91517 | 704-0026 | CO2 AIRWAY ADAPTER W/NAFION, PED/INF | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
45 | 10841522126390 | 91517 | 704-0024 | CO2 AIRWAY ADAPTER W/NAFION, PED/ADL | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
46 | 10841522126376 | 91517 | 704-0023 | CO2 AIRWAY ADAPTER, PEDIATRIC/ADULT | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
47 | 10841522126369 | 91517 | 704-0022 | CO2 ORAL/NASAL CANNULA W/O2, PEDIATRIC | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
48 | 10841522126352 | 91517 | 704-0020 | CO2 ORAL/NASAL CANNULA W/O2, ADULT | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
49 | 10841522105456 | 90478 | MDTM,MV1,ST,UHF 602-608MHZ | MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | 2 | Ultraview | |
50 | 10841522126338 | 91517 | 704-0017 | CO2 ORAL/NASAL CANNULA, ADULT | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | 2 | SPACELABS HEALTHCARE |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04250903202469 | v2.6 Global | 2092504-260 | The CardioDay Holter Analysis Software is designed for the acquisition, analysis The CardioDay 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 analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay system is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. | CardioDay | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
2 | 04250903202445 | Global SP04 | 2092504-254 | The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, ana 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 analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained operatorsunder the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. | CardioDay V2.5 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
3 | 04250903200144 | Global | 2092504-001 | The CardioDay V2.5 Holter Analysis Software is designed for the acquisition, ana 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 analysis are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The CardioDay V2.5 system is intended to be used by trained operatorsunder the direct supervision of a licensed healthcare practitioner in a hospital or clinic environment. | CardioDay V 2.5 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
4 | 04056869010205 | 11007642 | Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" descri Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22 | Sensis Vibe Combo | SIEMENS HEALTHCARE GMBH | |
5 | 04056869010199 | 11007641 | Device originally cleared as "Sensis"; Name change to "Sensis Vibe Hemo" describ Device originally cleared as "Sensis"; Name change to "Sensis Vibe Hemo" described in NFJ filed on 2016-03-22 | Sensis Vibe Hemo | SIEMENS HEALTHCARE GMBH | |
6 | 04056869010144 | 10764562 | Sensis Lite | SIEMENS HEALTHCARE GMBH | ||
7 | 04056869010137 | 10764561 | Sensis | SIEMENS HEALTHCARE GMBH | ||
8 | 03770019196007 | A001 | A001 | Cardiac Electrophysiology mapping tool | VX1 | SUBSTRATE HD |
9 | 00884838105034 | 6 | 830230 | The Information Management System is a software to acquire, display, trend, stor The Information Management System is a software to acquire, display, trend, store, and transmit physiologic, hemodynamic, clinical, medical images, and other related data. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
10 | 00884838100084 | 5 | 830230 | The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
11 | 00884838099340 | AltaTrack equipment | 4322 070 2535 X | The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FO The AltaTrack equipment is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a 3D image in real time of an AltaTrack Guidewire and/or AltaTrack Catheter and overlay it on real-time or pre-recorded 2D fluoroscopy images and/or on pre-operative 3D CT images, if available.The AltaTrack equipment comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component. | AltaTrack | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
12 | 00884838098985 | 2.6 | 98960612834x | The information management system is intended for use under the direct supervisi The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic, hemodynamic, clinical, medical image and other related data. The system is capable of processing / analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
13 | 00884838095229 | 733015 | The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiologic The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP)procedures. The KODEX-EPD™ System provides information about the electrical activity of theheart and about catheter location during the procedure. The system can be used on patients who areeligible for a conventional electrophysiological procedure. | KODEX-EPD System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
14 | 00884838094840 | ST80i Stress Test System | 860343 | Philips ST80i Stress System | Stress | PHILIPS MEDICAL SYSTEMS HSG |
15 | 00884838093478 | IntelliSpace ECG Management System | 860426 | "Provides for the acquisition, processing, storage, and distribution for resting "Provides for the acquisition, processing, storage, and distribution for resting ECGs from Philips PageWriter cardiographs, IntelliVue Monitoring Systems, and Telemedicine Systems as well as for Philips stress and Holter reports. Non-Philips devices optionally supported. Application software only. Does not include Windows Server 2012 or SQL Server 2014. North America: Includes remote software installation in customer-supplied compliant environment. Base editions and base upgrades include standard implementation. Custom or incremental services are quoted by the SCS or local organization with a Statement of Work. International Markets: Implementation services are not included and are quoted separately." | IECG | PHILIPS MEDICAL SYSTEMS HSG |
16 | 00884838091771 | 2.5 | 98960612665x | The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
17 | 00884838090750 | B.01 | IECG | PHILIPS MEDICAL SYSTEMS HSG | ||
18 | 00884838087330 | 2.4 | 98960612482x | The Xper Information Management System is used for acquiring, displaying, trendi The Xper Information Management System is used for acquiring, displaying, trending, storing and transmitting various types of data such as physiologic/hemodynamic, clinical, medical image and other related data. Its users, responsible to interpret the data provided, will be professional health care providers, such as physicians, registered nurses, cardiovascular technicians, radiology technicians, and other clinical health care providers. The system is capable of processing/analyzing information such as multi-channel ECG signals, displaying a graphical ST segment map and performing other data management functions such as creating reports. Data may be acquired from and/or sent to other devices such as physiological monitoring systems, information management systems, image acquisition/storage devices and other medical devices. The Xper Information Management System also provides optional ancillary functions, such as scheduling, inventory control, patient billing, statistical reporting, and other non-clinical modules. Users of the ancillary functions may be health care providers, but may also be nonclinical users authorized by the facility. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
19 | 00884838085213 | 2.3 | 98960612322x | The information management system is intended for use under the direct supervisi The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic/hemodynamic, clinical, medical image and other related data. The system is capable of processing/analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
20 | 00884838081291 | 2.2 | 453564649781 | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
21 | 00884838070721 | 2.1 | 453564530681 | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
22 | 00884838070691 | 1.5 | 453564495001 | Xper Information Management System | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | |
23 | 00884838032408 | B.01.00 | IECG | PHILIPS MEDICAL SYSTEMS HSG | ||
24 | 00884838030299 | 860343 | 860343 | Philips | PHILIPS MEDICAL SYSTEMS HSG | |
25 | 00869781000308 | Navik 3D v2.0 | 200-00668 | Navik 3D™ is a multi-component computer system that utilizes image processing me 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) fluoroscopic (fluoro) images. In addition, body surface electrocardiogram (ECG) and intracardiac electrogram (EGM) signals obtained from the patient recording and monitoring systems that already exist in the electrophysiology (EP) lab are digitized and displayed.Navik 3D utilizes data points from 3D catheter location and ECG-intracardiac EGM signals and uses this information to create and display 3D maps of the human heart. It does not require special catheters or patches, specially trained technicians, or fluoroscopy exposure beyond standard of care. | Navik 3D | APN HEALTH |
26 | 00869770000234 | K100A101X | ZIO SR ECG Monitoring Service | ZIO SR Patch | IRHYTHM TECHNOLOGIES, INC. | |
27 | 00869770000210 | A100A100X | ZIO AT ECG Monitoring Service | ZIO AT Patch | IRHYTHM TECHNOLOGIES, INC. | |
28 | 00869047000431 | 4.X.X | The VidiStar PACS & DICOM Viewer Software system is a picture archiving and comm The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. | VidiStar PACS & DICOM Viewer Software | FUJIFILM HEALTHCARE AMERICAS CORPORATION | |
29 | 00860991000362 | 6.2 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
30 | 00860991000355 | 6.1 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
31 | 00860991000348 | 6.0 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
32 | 00860991000331 | 5.4 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
33 | 00860991000324 | 5.3 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
34 | 00860991000317 | 5.2.0 | ECG Management System is a software only ECG management database that stores, di ECG Management System is a software only ECG management database that stores, displays, and prints high resolution ECG Data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
35 | 00860991000300 | 5.1.0 | ECG Management System is a software only EGG management database that stores, di ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data | Epiphany Cardio Server | EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC | |
36 | 00860007954177 | VMCU1 | vMap Control Unit | VEKTOR MEDICAL, INC. | ||
37 | 00860007954108 | VMDISP1 | vMap Disposables | VEKTOR MEDICAL, INC. | ||
38 | 00857560008010 | 1.2.5 | 113-01003 | The HealthView ECG Manager is a computer system, used within a clinical network, 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, send, and print ECGs and related digitized clinical documents through the use of on-screen measurement and editing tools. The system receives files (such as ECG, Stress, Holter, or PFT) from any compatible device, displaying such data to the clinician for analysis and review.The product does not modify the original ECG waveform and does not provide an automated ECG analysis. | HealthView ECG Manager | LUMEDX CORPORATION |
39 | 00857553006139 | D300 | D300 | Cardea SOLO PC Software - ECG analysis software (D300) | Cardea SOLO | CARDIAC INSIGHT, INC. |
40 | 00857553006092 | C300/D300 | C300/D300 | StealthView Software & Smart Cable - ECG analysis software (D300) and data trans StealthView Software & Smart Cable - ECG analysis software (D300) and data transfer cable (C300). | Stealth System S300 | CARDIAC INSIGHT, INC. |
41 | 00857042007999 | 900000 | 900000 | AcQMap System | AcQMap | ACUTUS MEDICAL, INC. |
42 | 00857042007920 | 900100 | 900100 | AcQMap System Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
43 | 00857042007876 | 800727 | 800727 | AcQMap to DiamondTemp Generator Adapter | DiamondTemp Generator Adapter | ACUTUS MEDICAL, INC. |
44 | 00857042007562 | 800605 | 800605 | AcQMap Patient Electrode Kit | AcQMap | ACUTUS MEDICAL, INC. |
45 | 00857042007425 | 800604 | 800604 | AcQMap Auxiliary Interface Box, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
46 | 00857042007388 | 800531 | 800531 | Cable, AcQMap Surface ECG Output (AHA) Packaged | AcQMap | ACUTUS MEDICAL, INC. |
47 | 00857042007364 | 800405 | 800405 | POAG Cable MC-POAG-EC6/2 | AcQMap | ACUTUS MEDICAL, INC. |
48 | 00857042007357 | 800255 | 800255 | Workstation Cable | AcQMap | ACUTUS MEDICAL, INC. |
49 | 00857042007333 | 800601 | 800601 | Power Cord, Console 2.0 | AcQMap | ACUTUS MEDICAL, INC. |
50 | 00857042007326 | 800505 | 800505 | AcQMap Ablation Reference Cable | AcQMap | ACUTUS MEDICAL, INC. |