|
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
|
1
|
AMRA MEDICAL AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASG SUPERCONDUCTORS S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ASPECT IMAGING LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASPECT IMAGING LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CANON MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
26
|
DEERFIELD IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ESAOTE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ESAOTE S.P.A. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FUJIFILM HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GE HEALTHCARE (TIANJIN) COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GE HEALTHCARE(TIANJIN) COMPANY LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GE MEDICAL SYSTEMS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HEARTVISTA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
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
|
2
|
HYPERFINE RESEARCH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HYPERFINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
INNOVERE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVY BIOMEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVY BIOMEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KINETICOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIMAGEMETRIC LLC |
|
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
|
MRIAUDIO |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRIAUDIO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYOCARDIAL SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOCOIL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEURO42, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NORDICNEUROLAB AS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NORTHH MEDICAL GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOUS IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERSPECTUM |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERSPECTUM DIAGNOSTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PERSPECTUM LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PERSPECTUM LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
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
|
1
|
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROMAXO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESOUNDANT INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
SHANGHAI UNITED IMAGING INTELLIGENCE 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
|
6
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
34
|
SIEMENS MEDICAL SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
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
|
SYNAPTIVE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SYNTHETICMR AB |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TERRAN BIOSCIENCES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIME MEDICAL LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TOSHIBA MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRACINNOVATIONS A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRACINNOVATIONS APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Canon Medical System, USA, INC. |
II |
Mar-04-2024 |
2 |
Canon Medical System, USA, INC. |
II |
Jul-09-2021 |
3 |
Canon Medical System, USA, INC. |
II |
Oct-22-2018 |
4 |
Deerfield Imaging |
II |
Mar-11-2016 |
5 |
Deerfield Imaging, Inc. |
II |
Dec-31-2019 |
6 |
Deerfield Imaging, Inc. |
II |
May-04-2018 |
7 |
Esaote S.p.A. |
II |
Jul-05-2016 |
8 |
GE Healthcare, LLC |
II |
Jul-21-2022 |
9 |
GE Healthcare, LLC |
II |
Apr-21-2022 |
10 |
GE Healthcare, LLC |
II |
Apr-04-2022 |
11 |
GE Healthcare, LLC |
II |
Feb-09-2022 |
12 |
GE Healthcare, LLC |
II |
Oct-16-2021 |
13 |
GE Healthcare, LLC |
II |
Jul-12-2021 |
14 |
GE Healthcare, LLC |
II |
Oct-20-2020 |
15 |
GE Healthcare, LLC |
II |
Jan-28-2020 |
16 |
GE Healthcare, LLC |
II |
Jan-07-2019 |
17 |
GE Healthcare, LLC |
II |
Feb-10-2017 |
18 |
GE Healthcare, LLC |
II |
Sep-02-2016 |
19 |
GE Healthcare, LLC |
II |
Jul-06-2016 |
20 |
GE Healthcare, LLC |
II |
Jun-08-2016 |
21 |
GE Medical Systems, LLC |
II |
Oct-24-2018 |
22 |
GE Medical Systems, LLC |
II |
Oct-15-2018 |
23 |
GE Medical Systems, LLC |
II |
Sep-27-2018 |
24 |
GE Medical Systems, LLC |
II |
Jul-23-2018 |
25 |
GE Medical Systems, LLC |
II |
Aug-02-2017 |
26 |
GE Medical Systems, LLC |
II |
Apr-07-2016 |
27 |
Hitachi Healthcare Americas Corporation |
II |
Aug-24-2021 |
28 |
Hitachi Medical Systems America Inc |
II |
Jul-18-2018 |
29 |
Hitachi Medical Systems America Inc |
II |
Mar-23-2017 |
30 |
Hitachi Medical Systems America Inc |
II |
Jan-26-2017 |
31 |
Invivo Corporation |
II |
Mar-04-2020 |
32 |
MWT Materials, Inc. |
II |
Jan-21-2016 |
33 |
Medtronic Navigation |
II |
Jul-06-2016 |
34 |
NordicNeuroLab AS |
II |
Sep-11-2018 |
35 |
NordicNeuroLab AS |
II |
Jun-06-2018 |
36 |
Philips Electronics North America Corporation |
II |
Apr-18-2018 |
37 |
Philips Electronics North America Corporation |
II |
Dec-19-2016 |
38 |
Philips Electronics North America Corporation |
II |
Feb-26-2016 |
39 |
Philips Medical Systems Nederlands |
II |
Apr-27-2019 |
40 |
Philips Medical Systems Nederlands |
II |
Feb-22-2019 |
41 |
Philips Medical Systems Nederlands |
II |
Jan-08-2019 |
42 |
Philips North America |
II |
Feb-02-2024 |
43 |
Philips North America |
III |
Jan-25-2024 |
44 |
Philips North America |
II |
Aug-11-2023 |
45 |
Philips North America |
II |
Aug-11-2023 |
46 |
Philips North America Llc |
I |
Dec-14-2023 |
47 |
Philips North America Llc |
II |
Nov-21-2023 |
48 |
Philips North America Llc |
II |
Dec-08-2022 |
49 |
Philips North America Llc |
II |
Sep-03-2021 |
50 |
Philips North America Llc |
II |
Aug-25-2021 |
51 |
Philips North America Llc |
II |
Jun-04-2021 |
52 |
Siemens Medical Solutions USA, Inc |
II |
Sep-29-2023 |
53 |
Siemens Medical Solutions USA, Inc |
II |
Sep-10-2021 |
54 |
Siemens Medical Solutions USA, Inc |
II |
Aug-22-2019 |
55 |
Siemens Medical Solutions USA, Inc |
II |
Apr-10-2017 |
56 |
Siemens Medical Solutions USA, Inc |
II |
May-03-2016 |
57 |
Toshiba American Medical Systems Inc |
II |
Jul-06-2016 |
|
|
|
|