|
Device |
computer, diagnostic, programmable |
Product Code | DQK |
Regulation Number |
870.1425
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ABBOTT ELECTROPHYSIOLOGY |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ABBOTT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
ABLACON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ACUTUS MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUTUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUTUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
ADAMS MEDITECH LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALIVECOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ANUMANA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APN HEALTH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B-SECUR LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOFOURMIS SINGAPORE PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSENSE WEBSTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
19
|
BIOSIG TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAMBRIDGE HEART, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIAC DESIGNS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIO TEK, BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOCALM SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOINSIGHT TECHNOLOGIES, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CARDIOINSIGHT TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIONXT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOTEK, B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION GERMANY 234 GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CATHETER PRECISION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CATHVISION APS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CENTERLINE BIOMEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CORDIANA MEDICAL INFORMATICS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COROVENTIS RESEARCH AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LFESCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFECIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFESCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFESCIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
EDWARDS LIFESIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPIPHANY HEALTHCARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMPLICITY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IRHYTHM TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
ITAMAR MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUMEDX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MCKESSON ISRAEL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDICALGORITHMICS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIGUIDE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MENNEN MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERGE HEALTHCARE INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MORTARA INSTRUMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS MEDICAL SYSTEM NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V. (PMSN) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUIPU S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADI MEDICAL SYSTEMS AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RHYTHM AI LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RHYTHM AL, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RHYTHMIA MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHWARZER CARDIOTEK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CAREWELL ELECTRONICS., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMART SOLUTIONS TECHNOLOGIES SL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPACELABS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPACELABS HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ST. JUDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
20
|
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL (NOW PART OF THE ABBOTT MEDICAL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STEREOTAXIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEMED SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOMTEC IMAGING SYSTEMS, GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOPERA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
VEKTOR MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOLTA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
APN Health LLC |
III |
Dec-14-2023 |
2 |
Abbott Laboratories Inc. (St Jude Medical) |
II |
Jun-14-2021 |
3 |
Baxter Healthcare Corporation |
II |
Sep-28-2023 |
4 |
Biosense Webster (israel), Ltd. |
II |
Aug-24-2020 |
5 |
Biosense Webster, Inc. |
II |
Sep-09-2016 |
6 |
Biosense Webster, Inc. |
II |
Oct-01-2015 |
7 |
Biosense Webster, Inc. |
II |
Feb-20-2014 |
8 |
Biosense Webster, Inc. |
II |
Mar-28-2013 |
9 |
Biosense Webster, Inc. |
II |
Sep-12-2012 |
10 |
Biosense Webster, Inc. |
II |
Mar-20-2012 |
11 |
Biosense Webster, Inc. |
III |
Mar-28-2011 |
12 |
Boston Scientific Corporation |
II |
Apr-27-2020 |
13 |
CHANGE HEALTHCARE CANADA COMPANY |
II |
Apr-08-2020 |
14 |
CardioTek BV |
II |
Jun-23-2022 |
15 |
CardioTek BV |
II |
Jun-30-2017 |
16 |
Change Healthcare Israel Ltd. |
II |
May-24-2019 |
17 |
Edwards Lifesciences, LLC |
II |
May-08-2020 |
18 |
Edwards Lifesciences, LLC |
II |
Jan-16-2018 |
19 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
May-14-2015 |
20 |
Fujifilm Medical Systems U.S.A., Inc. |
II |
May-14-2015 |
21 |
GE Healthcare Finland Oy |
II |
Oct-10-2018 |
22 |
GE Healthcare Finland Oy |
II |
Jul-02-2018 |
23 |
GE Healthcare, LLC |
II |
Apr-13-2022 |
24 |
GE Healthcare, LLC |
II |
Jun-22-2021 |
25 |
GE Healthcare, LLC |
II |
Oct-31-2019 |
26 |
GE Healthcare, LLC |
II |
Jul-23-2019 |
27 |
GE Healthcare, LLC |
II |
Apr-17-2013 |
28 |
GE Healthcare, LLC |
II |
Aug-14-2009 |
29 |
GE Medical Systems Information Technologies Inc |
II |
Jul-03-2024 |
30 |
GE Medical Systems Information Technologies Inc |
II |
Sep-19-2023 |
31 |
GE Medical Systems Information Technologies, Inc. |
II |
Jan-25-2018 |
32 |
Hitachi Healthcare Americas Corp Informatics Division |
II |
Sep-06-2018 |
33 |
Invivo Corporation |
II |
Nov-14-2018 |
34 |
McKesson Israel Ltd. |
II |
Aug-31-2018 |
35 |
McKesson Israel Ltd. |
II |
Jan-05-2015 |
36 |
McKesson Provider Technologies - Medical Imaging Group |
II |
Jan-13-2011 |
37 |
McKesson Provider Technologies - Medical Imaging Group |
II |
Jul-09-2010 |
38 |
McKesson Provider Technologies - Medical Imaging Group |
II |
Jun-24-2010 |
39 |
Merge Healthcare, Inc. |
II |
Aug-28-2021 |
40 |
Merge Healthcare, Inc. |
II |
Jan-14-2018 |
41 |
Merge Healthcare, Inc. |
II |
Jul-10-2017 |
42 |
Merge Healthcare, Inc. |
II |
Jun-29-2017 |
43 |
Merge Healthcare, Inc. |
II |
May-02-2017 |
44 |
Merge Healthcare, Inc. |
II |
Apr-11-2017 |
45 |
Merge Healthcare, Inc. |
II |
Mar-14-2017 |
46 |
Merge Healthcare, Inc. |
II |
Feb-15-2017 |
47 |
Merge Healthcare, Inc. |
II |
Jan-24-2017 |
48 |
Merge Healthcare, Inc. |
II |
Nov-28-2016 |
49 |
Merge Healthcare, Inc. |
II |
Aug-04-2016 |
50 |
Merge Healthcare, Inc. |
II |
Dec-28-2015 |
51 |
Merge Healthcare, Inc. |
II |
Aug-06-2015 |
52 |
Merge Healthcare, Inc. |
II |
Oct-28-2014 |
53 |
Philips Electronics North America Corporation |
II |
Dec-14-2018 |
54 |
Philips Medical Systems, Inc. |
II |
Aug-21-2014 |
55 |
Siemens Medical Solutions USA, Inc |
II |
Jul-25-2024 |
56 |
Siemens Medical Solutions USA, Inc |
II |
Jan-09-2024 |
57 |
Siemens Medical Solutions USA, Inc |
II |
Jan-01-2023 |
58 |
Siemens Medical Solutions USA, Inc |
III |
Aug-18-2022 |
59 |
Siemens Medical Solutions USA, Inc |
II |
Jul-20-2022 |
60 |
Siemens Medical Solutions USA, Inc |
II |
Jun-06-2022 |
61 |
Siemens Medical Solutions USA, Inc |
II |
Jan-14-2022 |
62 |
Siemens Medical Solutions USA, Inc |
II |
Apr-19-2021 |
63 |
Siemens Medical Solutions USA, Inc |
II |
Mar-04-2021 |
64 |
Siemens Medical Solutions USA, Inc |
II |
Aug-28-2020 |
65 |
Siemens Medical Solutions USA, Inc |
II |
Feb-23-2019 |
66 |
Siemens Medical Solutions USA, Inc |
II |
Jul-06-2017 |
67 |
Siemens Medical Solutions USA, Inc |
II |
May-24-2017 |
68 |
Siemens Medical Solutions USA, Inc |
II |
May-10-2012 |
69 |
Spacelabs Healthcare, Inc. |
II |
Jul-22-2019 |
70 |
Spacelabs Healthcare, Incorporated |
II |
Aug-25-2010 |
71 |
Spacelabs Healthcare, Llc |
II |
Mar-25-2014 |
72 |
Spacelabs Healthcare, Llc |
II |
Jan-17-2013 |
73 |
Spacelabs Healthcare, Llc |
II |
Jun-20-2012 |
74 |
Spacelabs Healthcare, Llc |
II |
Jun-22-2011 |
75 |
Spacelabs Healthcare, Ltd. |
II |
Dec-10-2020 |
76 |
St. Jude Medical |
II |
Apr-10-2009 |
|
|
|
|