1
00195278516015
AltiX
5896597
Upgrade Kit MLCL V8.0
MLCL Upgrade
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
2
00195278507525
AltiX
5889605
Software Medical Device GE Client Software V8.0
MLCL Client Software
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
3
00195278507051
AltiX
2300000-005
Computer ComboLab Acquisition v8.0
ComboLab
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
4
00195278507044
AltiX
2300000-004
Computer CardioLab Acquisition v8.0
CardioLab
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
5
00195278288639
MBZ323
2087075-300
CARESCAPE ONE MBZ323 ATO MODEL
CARESCAPE ONE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
6
00191506017224
H749009881CD0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
7
00191506017187
H749009765R0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
8
00191506015206
H749009881IZ0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
9
00191506015190
H749009881IR0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
10
00191506015183
H749009881I0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
11
00191506015176
H749009881CZ0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
12
00191506015169
H749009881CR0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
13
00191506015152
H749009881C0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
14
00191506015084
H7490097650
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
15
00191506000813
M004RAPATCH20
M004RAPATCH20
Location Reference Patch Kit
Rhythmia HDx™ Mapping System
BOSTON SCIENTIFIC CORPORATION
16
B972CCZ12050482050
4
CCZ1205048205
CER-S is stand-alone software medical device, providing advanced solutions for i
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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.
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CER-S
CARDIO CALM SRL
17
B972CCZ12050482030
4
CER-S is stand-alone software medical device, providing advanced solutions for i
(View more)
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.
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CER-S
CARDIO CALM SRL
18
B546VENDYS1
JK-001V
VENDYS II
ENDOTHELIX, INC.
19
B320VH120
VH12
Premier Heart MCG 12 Lead capture hardware.
Premier Heart MCG Model VH12
PREMIER HEART, LLC
20
B320MCGC0
MCGC
Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (
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Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
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Premier Heart MCG Analysis Software
PREMIER HEART, LLC
21
B320CF190
CF19
CF19
Premier Heart MCG Model CF19
Premier Heart MCG
PREMIER HEART, LLC
22
B273CEA0
2.1.xx
Cardiologs ECG analysis platform
Cardiologs Platform
CARDIOLOGS TECHNOLOGIES
23
80010939050027
14.0
McKesson Cardiology Hemo
MCKESSON TECHNOLOGIES INC.
24
80010939050010
13.2.1
McKesson Cardiology Hemo
MCKESSON TECHNOLOGIES INC.
25
80010939040028
14.0
McKesson Cardiology ECG Management
MCKESSON TECHNOLOGIES INC.
26
80010939040011
13.2.1
McKesson Cardiology ECG Management
MCKESSON TECHNOLOGIES INC.
27
20857553006072
M300-5
M300-5
Stealth System Wearable Sensor (M300).
Stealth System S300
CARDIAC INSIGHT, INC.
28
17540262120028
1.3
Change Healthcare Cardiology ECG Mobile
CHANGE HEALTHCARE ISRAEL LTD
29
17540262120011
1.2.4
Change Healthcare Cardiology ECG Mobile
CHANGE HEALTHCARE ISRAEL LTD
30
17540262110104
15.0.1
Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE CANADA COMPANY
31
17540262110098
15.0
Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE CANADA COMPANY
32
17540262110050
14.3.2
Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE CANADA COMPANY
33
17540262110043
14.3
Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE CANADA COMPANY
34
17540262110036
14.2
Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE CANADA COMPANY
35
17540262110029
14.1.1
Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE ISRAEL LTD
36
17540262110012
14.1
Change Healthcare Cardiology ECG Management
CHANGE HEALTHCARE ISRAEL LTD
37
17540262100105
15.0.1
Change Healthcare Cardiology Hemo
CHANGE HEALTHCARE CANADA COMPANY
38
17540262100099
15.0
Change Healthcare Cardiology Hemo
CHANGE HEALTHCARE CANADA COMPANY
39
17540262100051
14.3.2
Change Healthcare Cardiology Hemo
CHANGE HEALTHCARE CANADA COMPANY
40
17540262100044
14.3
Change Healthcare Cardiology Hemo
CHANGE HEALTHCARE CANADA COMPANY
41
17540262100037
14.2
Change Healthcare Cardiology Hemo
CHANGE HEALTHCARE CANADA COMPANY
42
17540262100020
14.1.1
Change Healthcare Cardiology Hemo
CHANGE HEALTHCARE ISRAEL LTD
43
17540262100013
14.1
Change Healthcare Cardiology Hemo
CHANGE HEALTHCARE ISRAEL LTD
44
15415067025934
EN0020-P
EN0020-P
Surface Electrode Kit
EnSite Precision™
ST. JUDE MEDICAL, INC.
45
10857553006129
C300/D300
C300/D300
Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer ca
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Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).
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Cardea SOLO
CARDIAC INSIGHT, INC.
46
10857553006112
M300-5
M300-5
Cardea SOLO Wearable Sensor (M300)
Cardea SOLO
CARDIAC INSIGHT, INC.
47
10846835012576
D128624
D128624
Carto 3
BIOSENSE WEBSTER INC
48
10846835011678
FG170000
FG170000
NOGA XP-Cardiac Mapping System
NOGA XP
BIOSENSE WEBSTER (ISRAEL) LTD.
49
10846835009439
D129707
D129707
Carto 3
BIOSENSE WEBSTER INC
50
10846835009422
D129704
D129704
Carto 3
BIOSENSE WEBSTER INC