Other products from "GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 04250903201172 130 cm, IEC Color Code, Round 2014606-635 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12 10 Leads
2 04250903201202 V1.2.1 2067634-056 The SEER 1000 Apple App is a software product which is an accessory to the SEER The SEER 1000 Apple App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 Apple App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 Apple App
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. DQK Computer, Diagnostic, Programmable 2 CardioDay V 2.5
4 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. DQK Computer, Diagnostic, Programmable 2 CardioDay
5 04250903200861 3 Leads (3 Channels), 105 cm (41 in), AHA Color Code 2067634-053 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
6 04250903200854 3 Leads (3 Channels), 61 cm (24 in), AHA Color Code 2067634-052 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
7 04250903200847 3 Leads (3 Channels), 105 cm (41 in), IEC Color Code 2067634-051 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
8 04250903200830 3 Leads (3 Channels), 61 cm (24 in), IEC Color Code 2067634-050 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
9 04250903200823 7 Leads (3 Channels), 105 cm (41 in), AHA Color Code 2067634-020 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
10 04250903200816 5 Leads (2 Channels), 105 cm (41 in), AHA Color Code 2067634-019 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
11 04250903200809 7 Leads (3 Channels), 61 cm (24 in), AHA Color Code 2067634-018 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
12 04250903200793 5 Leads (2 Channels), 61 cm (24 in), AHA Color Code 2067634-017 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
13 04250903200786 7 Leads (3 Channels), 105 cm (41 in), IEC Color Code 2067634-016 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
14 04250903200779 5 Leads (2 Channels), 105 cm (41 in), IEC Color Code 2067634-015 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
15 04250903200762 7 Leads (3 Channels), 61 cm (24 in), IEC Color Code 2067634-014 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
16 04250903200755 5 Leads (2 Channels), 61 cm (24 in), IEC Color Code 2067634-013 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 ECG Cable
17 04250903201219 5 Leads, 120 cm (90/30 cm), Colors: Red, Brown, Black, White, Green 2014606-185 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder). DSH Recorder, Magnetic Tape, Medical 2 ECG Cable for CM 3000 Series
18 04250903200298 Adapter for 7 Leadwires, 50 cm 2014606-074 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder). DSH Recorder, Magnetic Tape, Medical 2 ECG Trunk Cable for CM 3000 Series
19 04250903200274 Adapter for 5 Leadwires, 50 cm 2014606-071 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder). DSH Recorder, Magnetic Tape, Medical 2 ECG Trunk Cable for CM 3000 Series
20 04250903200267 Adapter for 7 Leadwires, 150 cm 2014606-044 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder). DSH Recorder, Magnetic Tape, Medical 2 ECG Trunk Cable for CM 3000 Series
21 04250903201738 10 Leads, 105 cm, AHA Color Code, Flat 2107229-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12
22 04250903201721 10 Leads, 130 cm, AHA Color Code, Round 2107228-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12
23 04250903201714 10 Leads, 105 cm, IEC Color Code, Flat 2104809-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12
24 04250903201707 10 Leads, 130 cm, IEC Color Code, Round 2104808-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12
25 04250903201189 10 Leads, 130 cm, AHA Color Code, Round 2014606-634 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12
26 04250903201165 10 Leads, 105 cm, AHA Color Code, Flat 2014606-636 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12
27 04250903201158 10 Leads, 105 cm, IEC Color Code, Flat 2014606-637 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000-12 BT, SEER 12 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for CM 3000-12 BT / SEER 12
28 04250903201691 3 Leads, 105 cm, AHA Color Code 2104822-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
29 04250903201684 3 Leads, 75 cm, AHA Color Code 2104821-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
30 04250903201677 3 Leads, 105 cm, IEC Color Code 2104819-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
31 04250903201660 3 Leads, 75 cm, IEC Color Code 2104818-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
32 04250903201653 7 Leads, 105 cm, AHA Color Code 2104817-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
33 04250903201646 5 Leads, 105 cm, AHA Color Code 2104816-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
34 04250903201639 7 Leads, 75 cm, AHA Color Code 2104815-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
35 04250903201622 5 Leads, 75 cm, AHA Color Code 2104814-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
36 04250903201615 7 Leads, 105 cm, IEC Color Code 2104813-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
37 04250903201608 5 Leads, 105 cm, IEC Color Code 2104812-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
38 04250903201592 7 Leads, 75 cm, IEC Color Code 2104811-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
39 04250903201585 5 Leads, 75 cm, IEC Color Code 2104810-001 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 ECG Cable for SEER 1000
40 04250903200748 7 day - Korean 2067634-012 The SEER 1000 digital Holter recorder is intended to continuously record ECG dat The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional. MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 SEER 1000
41 04250903200731 48 hour - Korean 2067634-011 The SEER 1000 digital Holter recorder is intended to continuously record ECG dat The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional. MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 SEER 1000
42 04250903200724 24 hour - Korean 2067634-010 The SEER 1000 digital Holter recorder is intended to continuously record ECG dat The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is in-tended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or healthcare professional. MWJ Electrocardiograph, Ambulatory (Without Analysis) 2 SEER 1000
43 04250903201196 V1.0SP03 2067634-055 The SEER 1000 PC App is a software product which is an accessory to the SEER 100 The SEER 1000 PC App is a software product which is an accessory to the SEER 1000 recorder. The SEER 1000 PC App assists in the hook-up procedure (e.g. displaying of ECG data and setting of patient demographic data). MWJ Electrocardiograph,Ambulatory(Without Analysis) 2 SEER 1000 PC App
44 04250903200281 5 Leads, 30 cm, Colors: Red, Brown, Black, White, Green 2014606-072 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder). DSH Recorder, Magnetic Tape, Medical 2 ECG Leadwire Set for CM 3000 Series
45 04250903200250 7 Leads, 60 cm, Colors: Red, Brown, Black, White, Green, Blue, Orange 2014606-039 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder). DSH Recorder, Magnetic Tape, Medical 2 ECG Leadwire Set for CM 3000 Series
46 04250903200243 5 Leads, 60 cm, Colors: Red, Brown, Black, White, Green 2014606-038 The cable is intended to be used to conduct electrical signals from a patient's The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine (CM 3000 recorder). DSH Recorder, Magnetic Tape, Medical 2 ECG Leadwire Set for CM 3000 Series
Other products with the same Product Code "DQK"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 04260441455425 40SYS02 EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a co EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. EP-TRACER CARDIOTEK B.V.
2 04260441455418 40SYS01 EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a co EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. EP-TRACER CARDIOTEK B.V.
3 04260441455326 32SYS02 EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. EP-TRACER CARDIOTEK B.V.
4 04260441450574 08ACC01 Aluminium carrying case CARDIOTEK B.V.
5 04260441450482 03UBC02 Adapter cables unipolar/ bipolar (set of 10) CARDIOTEK B.V.
6 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
7 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
8 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
9 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
10 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
11 04056869010144 10764562 Sensis Lite SIEMENS HEALTHCARE GMBH
12 04056869010137 10764561 Sensis SIEMENS HEALTHCARE GMBH
13 03770019196007 A001 A001 Cardiac Electrophysiology mapping tool VX1 SUBSTRATE HD
14 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.
15 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.
16 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.
17 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.
18 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.
19 00884838094840 ST80i Stress Test System 860343 Philips ST80i Stress System Stress PHILIPS MEDICAL SYSTEMS HSG
20 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
21 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.
22 00884838090750 B.01 IECG PHILIPS MEDICAL SYSTEMS HSG
23 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.
24 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.
25 00884838081291 2.2 453564649781 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
26 00884838070721 2.1 453564530681 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
27 00884838070691 1.5 453564495001 Xper Information Management System PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
28 00884838032408 B.01.00 IECG PHILIPS MEDICAL SYSTEMS HSG
29 00884838030299 860343 860343 Philips PHILIPS MEDICAL SYSTEMS HSG
30 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
31 00869770000234 K100A101X ZIO SR ECG Monitoring Service ZIO SR Patch IRHYTHM TECHNOLOGIES, INC.
32 00869770000210 A100A100X ZIO AT ECG Monitoring Service ZIO AT Patch IRHYTHM TECHNOLOGIES, INC.
33 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
34 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
35 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
36 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
37 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
38 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
39 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
40 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
41 00860007954177 VMCU1 vMap Control Unit VEKTOR MEDICAL, INC.
42 00860007954108 VMDISP1 vMap Disposables VEKTOR MEDICAL, INC.
43 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
44 00857553006139 D300 D300 Cardea SOLO PC Software - ECG analysis software (D300) Cardea SOLO CARDIAC INSIGHT, INC.
45 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.
46 00857042007999 900000 900000 AcQMap System AcQMap ACUTUS MEDICAL, INC.
47 00857042007920 900100 900100 AcQMap System Console 2.0 AcQMap ACUTUS MEDICAL, INC.
48 00857042007876 800727 800727 AcQMap to DiamondTemp Generator Adapter DiamondTemp Generator Adapter ACUTUS MEDICAL, INC.
49 00857042007562 800605 800605 AcQMap Patient Electrode Kit AcQMap ACUTUS MEDICAL, INC.
50 00857042007425 800604 800604 AcQMap Auxiliary Interface Box, Console 2.0 AcQMap ACUTUS MEDICAL, INC.