|
Device |
system, nuclear magnetic resonance imaging |
Product Code | LNH |
Regulation Number |
892.1000
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AMRA MEDICAL AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASG SUPERCONDUCTORS S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ASPECT IMAGING LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ASPECT IMAGING LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CANON MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
27
|
CLEARMRI SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEERFIELD IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIAGNOSOFT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ESAOTE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ESAOTE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
ESAOTE, S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
FUJIFILM HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GE HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE (TIANJIN) COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GE HEALTHCARE JAPAN CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE HEALTHCARE(TIANJIN) COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
21
|
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEARTVISTA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
HEURON CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI HEALTHCARE AMERICAS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HITACHI HEALTHCARE AMERICAS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
HYPERFINE RESEARCH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HYPERFINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
IMRIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INNOVERE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVY BIOMEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVY BIOMEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JIANGSU MAGSPIN INSTRUMENT CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KINETICOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIAONING KAMPO MEDICAL SYSTEM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL NUMERICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL VISORS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIMAGEMETRIC LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTEC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC NAVIGATION ISRAEL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEVIS MEDICAL SOLUTIONS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIRADA MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRI DIVISION, BEIJING WANDONG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRI DIVISION,BEIJING WANDONG MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRI-TECH SP. ZO.O. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRIAUDIO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRIAUDIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYOCARDIAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOCOIL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NEURO42, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO XINGAOYI MAGNETISM CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORDICNEUROLAB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NORDICNEUROLAB AS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NORTHH MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOUS IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OLEA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPTOACOUSTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAMED S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PARAMED SRL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PERSPECTUM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERSPECTUM DIAGNOSTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PERSPECTUM LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERSPECTUM LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
18
|
PHILIPS MEDICAL SYSTEMS NEDERLAND BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PRISM CLINICAL IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PROMAXO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RESOUNDANT INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROBIN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ANKE HIGH-TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN RF TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTION USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
49
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SIEMENS MEDICAL SOLUTIONS, USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS, USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SINO CANADA HEALTH ENGINEERING RESEARCH INSTITUTE (HEFEI) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINTECH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SUZHOU ANKE MEDICAL SYSTEM CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNAPTIVE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHETICMR AB |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SYNTHETICMR AB (PUBL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERRAN BIOSCIENCES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIME MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TOSHIBA AMERICA MEDICAL SYSTEMS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSHIBA MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
13
|
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TRACINNOVATIONS A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRACINNOVATIONS APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XBO MEDICAL SYSTEMS CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XIOAO MDT TECHNOLOGY CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Alltech Medical Systems America Inc |
I |
Feb-18-2015 |
2 |
Canon Medical System, USA, INC. |
II |
Mar-04-2024 |
3 |
Canon Medical System, USA, INC. |
II |
Jul-09-2021 |
4 |
Canon Medical System, USA, INC. |
II |
Oct-22-2018 |
5 |
Deerfield Imaging |
II |
Mar-11-2016 |
6 |
Deerfield Imaging, Inc. |
II |
Dec-31-2019 |
7 |
Deerfield Imaging, Inc. |
II |
May-04-2018 |
8 |
Esaote S.p.A. |
II |
Jul-05-2016 |
9 |
GE Healthcare |
II |
Nov-10-2015 |
10 |
GE Healthcare |
II |
Aug-05-2015 |
11 |
GE Healthcare |
II |
Mar-20-2015 |
12 |
GE Healthcare |
I |
Feb-18-2015 |
13 |
GE Healthcare, LLC |
II |
Jul-21-2022 |
14 |
GE Healthcare, LLC |
II |
Apr-21-2022 |
15 |
GE Healthcare, LLC |
II |
Apr-04-2022 |
16 |
GE Healthcare, LLC |
II |
Feb-09-2022 |
17 |
GE Healthcare, LLC |
II |
Oct-16-2021 |
18 |
GE Healthcare, LLC |
II |
Jul-12-2021 |
19 |
GE Healthcare, LLC |
II |
Oct-20-2020 |
20 |
GE Healthcare, LLC |
II |
Jan-28-2020 |
21 |
GE Healthcare, LLC |
II |
Jan-07-2019 |
22 |
GE Healthcare, LLC |
II |
Feb-10-2017 |
23 |
GE Healthcare, LLC |
II |
Sep-02-2016 |
24 |
GE Healthcare, LLC |
II |
Jul-06-2016 |
25 |
GE Healthcare, LLC |
II |
Jun-08-2016 |
26 |
GE Healthcare, LLC |
II |
May-01-2014 |
27 |
GE Healthcare, LLC |
II |
Apr-21-2014 |
28 |
GE Healthcare, LLC |
II |
Sep-27-2013 |
29 |
GE Healthcare, LLC |
II |
Sep-23-2013 |
30 |
GE Healthcare, LLC |
II |
Aug-09-2013 |
31 |
GE Healthcare, LLC |
II |
May-01-2013 |
32 |
GE Healthcare, LLC |
II |
May-01-2013 |
33 |
GE Healthcare, LLC |
II |
Apr-11-2013 |
34 |
GE Healthcare, LLC |
II |
Mar-11-2013 |
35 |
GE Healthcare, LLC |
II |
Feb-21-2012 |
36 |
GE Healthcare, LLC |
II |
Oct-26-2011 |
37 |
GE Healthcare, LLC |
II |
Sep-01-2011 |
38 |
GE Healthcare, LLC |
II |
Feb-24-2011 |
39 |
GE Healthcare, LLC |
II |
Feb-18-2011 |
40 |
GE Healthcare, LLC |
II |
Nov-24-2010 |
41 |
GE Healthcare, LLC |
II |
Nov-19-2010 |
42 |
GE Medical Systems, LLC |
II |
Oct-24-2018 |
43 |
GE Medical Systems, LLC |
II |
Oct-15-2018 |
44 |
GE Medical Systems, LLC |
II |
Sep-27-2018 |
45 |
GE Medical Systems, LLC |
II |
Jul-23-2018 |
46 |
GE Medical Systems, LLC |
II |
Aug-02-2017 |
47 |
GE Medical Systems, LLC |
II |
Apr-07-2016 |
48 |
GE Medical Systems, LLC |
II |
Dec-28-2015 |
49 |
GE Medical Systems, LLC |
II |
Oct-30-2015 |
50 |
GE Medical Systems, LLC |
II |
Jan-11-2010 |
51 |
GE Medical Systems, LLC |
II |
Aug-25-2009 |
52 |
GE Medical Systems, LLC |
II |
Jun-30-2009 |
53 |
Hitachi Healthcare Americas Corporation |
II |
Aug-24-2021 |
54 |
Hitachi Medical Systems America Inc |
II |
Jul-18-2018 |
55 |
Hitachi Medical Systems America Inc |
II |
Mar-23-2017 |
56 |
Hitachi Medical Systems America Inc |
II |
Jan-26-2017 |
57 |
Hitachi Medical Systems America Inc |
II |
Sep-02-2014 |
58 |
Hitachi Medical Systems America Inc |
II |
Jun-19-2013 |
59 |
Hitachi Medical Systems America Inc |
II |
Aug-23-2012 |
60 |
Innovative Magnetic Resonance Imaging Systems Inc. |
II |
Nov-21-2012 |
61 |
Invivo Corporation |
II |
Mar-04-2020 |
62 |
MWT Materials, Inc. |
II |
Jan-21-2016 |
63 |
Medtronic Navigation |
II |
Jul-06-2016 |
64 |
NordicNeuroLab AS |
II |
Sep-11-2018 |
65 |
NordicNeuroLab AS |
II |
Jun-06-2018 |
66 |
Odin Medical Technologies Ltd. |
II |
Aug-19-2010 |
67 |
Philips Electronics North America Corporation |
II |
Apr-18-2018 |
68 |
Philips Electronics North America Corporation |
II |
Dec-19-2016 |
69 |
Philips Electronics North America Corporation |
II |
Feb-26-2016 |
70 |
Philips Electronics North America Corporation |
II |
Jul-22-2015 |
71 |
Philips Medical Systems (Cleveland) Inc |
II |
Oct-21-2013 |
72 |
Philips Medical Systems (Cleveland) Inc |
II |
Nov-28-2011 |
73 |
Philips Medical Systems (Cleveland) Inc |
II |
Feb-19-2010 |
74 |
Philips Medical Systems Nederlands |
II |
Apr-27-2019 |
75 |
Philips Medical Systems Nederlands |
II |
Feb-22-2019 |
76 |
Philips Medical Systems Nederlands |
II |
Jan-08-2019 |
77 |
Philips Medical Systems Nederlands |
II |
Feb-29-2012 |
78 |
Philips Medical Systems North America Co. Phillips |
II |
Mar-01-2011 |
79 |
Philips Medical Systems North America Co. Phillips |
II |
Dec-21-2010 |
80 |
Philips Medical Systems North America Co. Phillips |
II |
Nov-26-2010 |
81 |
Philips Medical Systems North America Co. Phillips |
II |
Sep-17-2010 |
82 |
Philips Medical Systems, Inc. |
II |
Nov-23-2015 |
83 |
Philips Medical Systems, Inc. |
II |
Oct-19-2015 |
84 |
Philips Medical Systems, Inc. |
II |
Mar-20-2015 |
85 |
Philips Medical Systems, Inc. |
II |
Jun-24-2014 |
86 |
Philips Medical Systems, Inc. |
II |
Jun-18-2014 |
87 |
Philips North America |
II |
Feb-02-2024 |
88 |
Philips North America |
III |
Jan-25-2024 |
89 |
Philips North America |
II |
Aug-11-2023 |
90 |
Philips North America |
II |
Aug-11-2023 |
91 |
Philips North America Llc |
II |
Apr-17-2024 |
92 |
Philips North America Llc |
I |
Dec-14-2023 |
93 |
Philips North America Llc |
II |
Nov-21-2023 |
94 |
Philips North America Llc |
II |
Dec-08-2022 |
95 |
Philips North America Llc |
II |
Sep-03-2021 |
96 |
Philips North America Llc |
II |
Aug-25-2021 |
97 |
Philips North America Llc |
II |
Jun-04-2021 |
98 |
Siemens Medical Solutions USA, Inc |
II |
Sep-29-2023 |
99 |
Siemens Medical Solutions USA, Inc |
II |
Sep-10-2021 |
100 |
Siemens Medical Solutions USA, Inc |
II |
Aug-22-2019 |
|
|
|
|