No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 17540262130089 | 1.0.7 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
2 | 17540262130072 | 1.0.6 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
3 | 17540262130065 | 1.0.5 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
4 | 17540262130058 | 1.0.4 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
5 | 17540262130041 | 1.0.3 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network Viewer | ||
6 | 17540262130034 | 1.0.2 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network™ Viewer | ||
7 | 17540262130027 | 1.0.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network Viewer | ||
8 | 17540262130010 | 1.0.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Imaging Network Viewer | ||
9 | 17540262150018 | 1.0.0 | QIH | Automated Radiological Image Processing Software | 2 | Change Healthcare Anatomical AI™ | ||
10 | 17540262140026 | 25.0 | LLZ | System, Image Processing, Radiological | 2 | Nucleus.io | ||
11 | 17540262140019 | 24 | LLZ | System, Image Processing, Radiological | 2 | Nucleus.io | ||
12 | 17540262040029 | 2.2.0 | LLZ | System, Image Processing, Radiological | 2 | Conserus Enterprise Viewer | ||
13 | 17540262040012 | 2.1 | LLZ | System, Image Processing, Radiological | 2 | Conserus Enterprise Viewer | ||
14 | 17540262130126 | 1.0.11 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
15 | 17540262130119 | 1.0.10 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
16 | 17540262130102 | 1.0.9 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
17 | 17540262130096 | 1.0.8 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging Viewer | ||
18 | 17540262110050 | 14.3.2 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
19 | 17540262110043 | 14.3 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
20 | 17540262110036 | 14.2 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
21 | 17540262160055 | 1.0.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
22 | 17540262160048 | 1.1.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
23 | 17540262160031 | 1.0.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
24 | 17540262160024 | 0.7.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
25 | 17540262160017 | 0.6.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Stratus Imaging PACS | ||
26 | 17540262020021 | 12.4 | LLZ | System, Image Processing, Radiological | 2 | McKesson Radiology | ||
27 | 17540262020014 | 12.3 | LLZ | System, Image Processing, Radiological | 2 | McKesson Radiology | ||
28 | 17540262010046 | 2.1.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Viewer | ||
29 | 17540262010039 | 2.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Viewer | ||
30 | 17540262010022 | 2.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Enterprise Viewer | ||
31 | 17540262100044 | 14.3 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
32 | 17540262100037 | 14.2 | MWI,DQK | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms),Compute Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms),Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology Hemo | ||
33 | 17540262110104 | 15.0.1 | DQK | Computer, Diagnostic, Programmable | 2 | Change Healthcare Cardiology ECG Management | ||
34 | 17540262100105 | 15.0.1 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
35 | 17540262100099 | 15.0 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
36 | 17540262100051 | 14.3.2 | DQK,MWI | Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrh Computer, Diagnostic, Programmable,Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | Change Healthcare Cardiology Hemo | ||
37 | 17540262090116 | 15.0.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology | ||
38 | 17540262090109 | 15.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology | ||
39 | 17540262090055 | 14.3.2 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology | ||
40 | 17540262090048 | 14.3 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology | ||
41 | 17540262030037 | 14.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Radiology Solutions | ||
42 | 17540262030020 | 14.0 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Radiology Solutions | ||
43 | 17540262030013 | 12.4.1 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Radiology Solutions | ||
44 | 17540262090031 | 14.2 | LLZ | System, Image Processing, Radiological | 2 | Change Healthcare Cardiology |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B972CCZ12050482050 | 4 | CCZ1205048205 | CER-S is stand-alone software medical device, providing advanced solutions for i CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data. | CER-S | CARDIO CALM SRL |
2 | B972CCZ12050482030 | 4 | CER-S is stand-alone software medical device, providing advanced solutions for i CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data. | CER-S | CARDIO CALM SRL | |
3 | B546VENDYS1 | JK-001V | VENDYS II | ENDOTHELIX, INC. | ||
4 | B320VH120 | VH12 | Premier Heart MCG 12 Lead capture hardware. | Premier Heart MCG Model VH12 | PREMIER HEART, LLC | |
5 | B320MCGC0 | MCGC | Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client ( Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine | Premier Heart MCG Analysis Software | PREMIER HEART, LLC | |
6 | B320CF190 | CF19 | CF19 | Premier Heart MCG Model CF19 | Premier Heart MCG | PREMIER HEART, LLC |
7 | B273CEA0 | 2.1.xx | Cardiologs ECG analysis platform | Cardiologs Platform | CARDIOLOGS TECHNOLOGIES | |
8 | 80010939050027 | 14.0 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
9 | 80010939050010 | 13.2.1 | McKesson Cardiology Hemo | MCKESSON TECHNOLOGIES INC. | ||
10 | 80010939040028 | 14.0 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
11 | 80010939040011 | 13.2.1 | McKesson Cardiology ECG Management | MCKESSON TECHNOLOGIES INC. | ||
12 | 20857553006072 | M300-5 | M300-5 | Stealth System Wearable Sensor (M300). | Stealth System S300 | CARDIAC INSIGHT, INC. |
13 | 17540262120028 | 1.3 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
14 | 17540262120011 | 1.2.4 | Change Healthcare Cardiology ECG Mobile | CHANGE HEALTHCARE ISRAEL LTD | ||
15 | 17540262110104 | 15.0.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
16 | 17540262110098 | 15.0 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
17 | 17540262110050 | 14.3.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
18 | 17540262110043 | 14.3 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
19 | 17540262110036 | 14.2 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE CANADA COMPANY | ||
20 | 17540262110029 | 14.1.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE ISRAEL LTD | ||
21 | 17540262110012 | 14.1 | Change Healthcare Cardiology ECG Management | CHANGE HEALTHCARE ISRAEL LTD | ||
22 | 17540262100105 | 15.0.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
23 | 17540262100099 | 15.0 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
24 | 17540262100051 | 14.3.2 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
25 | 17540262100044 | 14.3 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
26 | 17540262100037 | 14.2 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE CANADA COMPANY | ||
27 | 17540262100020 | 14.1.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE ISRAEL LTD | ||
28 | 17540262100013 | 14.1 | Change Healthcare Cardiology Hemo | CHANGE HEALTHCARE ISRAEL LTD | ||
29 | 15415067025934 | EN0020-P | EN0020-P | Surface Electrode Kit | EnSite Precision™ | ST. JUDE MEDICAL, INC. |
30 | 10857553006129 | C300/D300 | C300/D300 | Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer ca Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300). | Cardea SOLO | CARDIAC INSIGHT, INC. |
31 | 10857553006112 | M300-5 | M300-5 | Cardea SOLO Wearable Sensor (M300) | Cardea SOLO | CARDIAC INSIGHT, INC. |
32 | 10846835012576 | D128624 | D128624 | Carto 3 | BIOSENSE WEBSTER INC | |
33 | 10846835011678 | FG170000 | FG170000 | NOGA XP-Cardiac Mapping System | NOGA XP | BIOSENSE WEBSTER (ISRAEL) LTD. |
34 | 10846835009439 | D129707 | D129707 | Carto 3 | BIOSENSE WEBSTER INC | |
35 | 10846835009422 | D129704 | D129704 | Carto 3 | BIOSENSE WEBSTER INC | |
36 | 10846835008913 | D128709 | D128709 | N/A | BIOSENSE WEBSTER INC | |
37 | 10846835008906 | D128627 | D128627 | CARTO 3 | BIOSENSE WEBSTER INC | |
38 | 10846835008890 | D128623 | D128623 | N/A | BIOSENSE WEBSTER INC | |
39 | 10846835008883 | D128622 | D128622 | CARTO 3 | BIOSENSE WEBSTER INC | |
40 | 10846835003925 | CY1212CT | CY1212CT | Carto 3 | BIOSENSE WEBSTER INC | |
41 | 10846835003918 | CY1210CT | CY1210CT | Carto 3 | BIOSENSE WEBSTER INC | |
42 | 10846835003871 | CR3434CT | CR3434CT | Carto 3 | BIOSENSE WEBSTER INC | |
43 | 10846835003857 | CR3425CT | CR3425CT | Carto 3 | BIOSENSE WEBSTER INC | |
44 | 10846835003826 | CG2025CT | CG2025CT | Carto 3 | BIOSENSE WEBSTER INC | |
45 | 10846835003802 | CB3434CT | CB3434CT | Carto 3 | BIOSENSE WEBSTER INC | |
46 | 10846835003796 | CB3412CT | CB3412CT | Carto 3 | BIOSENSE WEBSTER INC | |
47 | 10846835003789 | CB3410CT | CB3410CT | Carto 3 | BIOSENSE WEBSTER INC | |
48 | 10846835000870 | FG540000 | FG-5400-00 | CARTO 3 | CARTO 3 | BIOSENSE WEBSTER (ISRAEL) LTD. |
49 | 10841522129551 | 98201 | 040-1766-00 | UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC |
50 | 10841522129537 | 98000 | 98000SL | PATHFINDER SL ANALYSER | PATHFINDER | SPACELABS HEALTHCARE (WASHINGTON), INC |