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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, nuclear magnetic resonance imaging
Product CodeLNH
Regulation Number 892.1000
Device Class 2


Premarket Reviews
ManufacturerDecision
AMRA MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
ASG SUPERCONDUCTORS S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 26
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
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 3
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE)
  SUBSTANTIALLY EQUIVALENT 2
HEARTVISTA, INC.
  SUBSTANTIALLY EQUIVALENT 2
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
HYPERFINE RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 8
INNOVERE MEDICAL 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, INC.
  SUBSTANTIALLY EQUIVALENT 1
MYOCARDIAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MYOCARDIAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOSCAN SOLUTION GMBH
  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 1
PERSPECTUM LTD
  SUBSTANTIALLY EQUIVALENT 2
PERSPECTUM LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 6
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
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 2
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
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 5
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 22
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 2
SPRINGBOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SYNTHETICMR AB
  SUBSTANTIALLY EQUIVALENT 3
SYNTHETICMR AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 1
TERRAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
TRACINNOVATIONS A/S
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 157 157
2020 98 98
2021 83 83
2022 138 138
2023 159 159
2024 94 94

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 183 183
Use of Device Problem 145 145
Improper or Incorrect Procedure or Method 128 128
Insufficient Information 122 122
Patient-Device Incompatibility 21 21
Device Handling Problem 18 18
Patient Device Interaction Problem 18 18
Temperature Problem 16 16
Electromagnetic Interference 14 14
No Apparent Adverse Event 14 14
Excessive Heating 12 12
Overheating of Device 11 11
Device-Device Incompatibility 9 9
Fire 9 9
Detachment of Device or Device Component 9 9
Poor Quality Image 7 7
Misassembled During Installation 7 7
Noise, Audible 6 6
Arcing 6 6
Break 6 6
Output Problem 6 6
Appropriate Term/Code Not Available 6 6
Unintended Movement 6 6
Smoking 6 6
Defective Device 6 6
Connection Problem 5 5
Protective Measures Problem 5 5
Electrical Overstress 5 5
Device Emits Odor 5 5
Thermal Decomposition of Device 5 5
Mechanical Jam 4 4
Electrical /Electronic Property Problem 4 4
Unexpected Therapeutic Results 4 4
Device Unsafe to Use in Environment 4 4
Therapeutic or Diagnostic Output Failure 4 4
Mechanical Problem 4 4
Unintended Collision 3 3
Positioning Problem 3 3
Electromagnetic Compatibility Problem 3 3
Malposition of Device 3 3
Melted 3 3
Unintended Electrical Shock 3 3
Computer Software Problem 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Inadequate User Interface 2 2
Unexpected Shutdown 2 2
Loose or Intermittent Connection 2 2
Human-Device Interface Problem 2 2
Nonstandard Device 2 2
Inadequacy of Device Shape and/or Size 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 93 93
No Clinical Signs, Symptoms or Conditions 88 88
Burn(s) 73 73
Bone Fracture(s) 57 57
Tinnitus 51 51
Pain 49 49
Full thickness (Third Degree) Burn 48 48
Superficial (First Degree) Burn 37 37
Laceration(s) 36 36
Patient Problem/Medical Problem 35 35
Injury 35 35
Burning Sensation 35 35
Hearing Impairment 31 31
Burn, Thermal 27 28
Blister 23 23
Insufficient Information 22 22
No Known Impact Or Consequence To Patient 21 21
Erythema 21 21
Hearing Loss 11 11
Unspecified Tissue Injury 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Headache 10 10
Swelling 10 10
Partial Hearing Loss 10 10
Radiation Burn 9 9
Skin Burning Sensation 8 8
Multiple Fractures 8 8
Skin Irritation 7 7
Discomfort 7 7
No Patient Involvement 6 6
No Consequences Or Impact To Patient 5 5
Electric Shock 5 5
Rash 5 5
Nausea 5 5
No Code Available 5 5
Skin Inflammation 5 5
Sleep Dysfunction 5 5
Cardiac Arrest 4 4
Tissue Damage 4 4
Bruise/Contusion 4 4
Swelling/ Edema 4 4
Abrasion 4 4
Numbness 4 4
Ambulation Difficulties 4 4
Head Injury 4 4
Unspecified Ear or Labyrinth Problem 3 3
Skin Discoloration 3 3
Neck Pain 3 3
Implant Pain 3 3
Peeling 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Jun-09-2024
2 Canon Medical System, USA, INC. II Mar-04-2024
3 Canon Medical System, USA, INC. II Jul-09-2021
4 Deerfield Imaging, Inc. II Dec-31-2019
5 GE Healthcare, LLC II Jul-21-2022
6 GE Healthcare, LLC II Apr-21-2022
7 GE Healthcare, LLC II Apr-04-2022
8 GE Healthcare, LLC II Feb-09-2022
9 GE Healthcare, LLC II Oct-16-2021
10 GE Healthcare, LLC II Jul-12-2021
11 GE Healthcare, LLC II Oct-20-2020
12 GE Healthcare, LLC II Jan-28-2020
13 GE Healthcare, LLC II Jan-07-2019
14 GE Medical Systems, LLC II Aug-02-2024
15 Hitachi Healthcare Americas Corporation II Aug-24-2021
16 Invivo Corporation II Mar-04-2020
17 Philips Medical Systems Nederlands II Apr-27-2019
18 Philips Medical Systems Nederlands II Feb-22-2019
19 Philips Medical Systems Nederlands II Jan-08-2019
20 Philips North America II Feb-02-2024
21 Philips North America III Jan-25-2024
22 Philips North America II Aug-11-2023
23 Philips North America II Aug-11-2023
24 Philips North America Llc II Sep-20-2024
25 Philips North America Llc II Jun-04-2024
26 Philips North America Llc II May-17-2024
27 Philips North America Llc II May-15-2024
28 Philips North America Llc II Apr-17-2024
29 Philips North America Llc I Dec-14-2023
30 Philips North America Llc II Nov-21-2023
31 Philips North America Llc II Dec-08-2022
32 Philips North America Llc II Sep-03-2021
33 Philips North America Llc II Aug-25-2021
34 Philips North America Llc II Jun-04-2021
35 Siemens Medical Solutions USA, Inc II Sep-29-2023
36 Siemens Medical Solutions USA, Inc II Sep-10-2021
37 Siemens Medical Solutions USA, Inc II Aug-22-2019
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