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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
Regulation Description Magnetic resonance diagnostic device.
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 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 24
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 5
GE MEDICAL SYSTEMS,LLC (GE HEALTHCARE)
  SUBSTANTIALLY EQUIVALENT 2
HEARTVISTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEURON CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
HYPERFINE RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 10
INNOVERE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU LICI MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOSCAN SOLUTION GMBH
  SUBSTANTIALLY EQUIVALENT 1
NEURO42, INC.
  SUBSTANTIALLY EQUIVALENT 1
NORDICNEUROLAB AS
  SUBSTANTIALLY EQUIVALENT 1
NORTHH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
NOUS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM LTD
  SUBSTANTIALLY EQUIVALENT 2
PERSPECTUM LTD.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 5
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
PRENUVO
  SUBSTANTIALLY EQUIVALENT 1
PROMAXO, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUALITY ELECTRODYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 6
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 SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 19
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 2
SYNTHETICMR AB (PUBL)
  SUBSTANTIALLY EQUIVALENT 1
SYNTHETICMR AB (PUBL.)
  SUBSTANTIALLY EQUIVALENT 1
TERRAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS A/S
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 98 98
2021 83 83
2022 138 138
2023 159 159
2024 281 281
2025 907 907

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 991 991
Insufficient Information 165 165
Improper or Incorrect Procedure or Method 147 147
Adverse Event Without Identified Device or Use Problem 140 140
Use of Device Problem 96 96
Device Handling Problem 23 23
Patient Device Interaction Problem 18 18
Patient-Device Incompatibility 16 16
Excessive Heating 16 16
No Apparent Adverse Event 15 15
Electromagnetic Interference 9 9
Fire 8 8
Electrical Overstress 7 7
Temperature Problem 6 6
Device-Device Incompatibility 6 6
Output Problem 6 6
Overheating of Device 6 6
Unintended Movement 6 6
Appropriate Term/Code Not Available 6 6
Defective Device 6 6
Misassembled During Installation 6 6
Device Emits Odor 5 5
Break 5 5
Mechanical Jam 5 5
Poor Quality Image 5 5
Smoking 5 5
Connection Problem 5 5
Noise, Audible 4 4
Arcing 4 4
Protective Measures Problem 4 4
Electrical /Electronic Property Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Inadequacy of Device Shape and/or Size 3 3
Electromagnetic Compatibility Problem 3 3
Device Unsafe to Use in Environment 3 3
Thermal Decomposition of Device 3 3
Melted 3 3
Unexpected Therapeutic Results 3 3
Positioning Problem 3 3
Unintended Electrical Shock 3 3
Unintended Collision 3 3
Defective Component 2 2
Collapse 2 2
Computer Software Problem 2 2
Malposition of Device 2 2
Mechanical Problem 2 2
Unexpected Shutdown 2 2
Inadequate User Interface 2 2
Compatibility Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1077 1077
Partial thickness (Second Degree) Burn 84 84
Burn(s) 56 56
Full thickness (Third Degree) Burn 51 51
Bone Fracture(s) 48 48
Pain 47 47
Tinnitus 44 44
Laceration(s) 42 42
Superficial (First Degree) Burn 40 40
Burning Sensation 37 37
Blister 27 27
Insufficient Information 26 26
Hearing Impairment 25 25
Erythema 18 18
Partial Hearing Loss 16 16
Patient Problem/Medical Problem 13 13
Headache 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Burn, Thermal 11 11
Unspecified Tissue Injury 11 11
Injury 10 10
No Known Impact Or Consequence To Patient 10 10
Skin Burning Sensation 10 10
Multiple Fractures 9 9
Discomfort 7 7
Rash 7 7
Nausea 6 6
Swelling/ Edema 5 5
Electric Shock 5 5
No Patient Involvement 5 5
Unspecified Musculoskeletal problem 5 5
Ambulation Difficulties 5 5
Sleep Dysfunction 5 5
Shaking/Tremors 4 4
Radiation Burn 4 4
Alteration in Body Temperature 4 4
Dizziness 4 4
Hot Flashes/Flushes 4 4
Bruise/Contusion 4 4
Muscle Weakness 4 4
Unspecified Ear or Labyrinth Problem 4 4
Cardiac Arrest 4 4
High Blood Pressure/ Hypertension 4 4
Limb Fracture 3 3
Eye Injury 3 3
Blurred Vision 3 3
Ulcer 3 3
Fall 3 3
Dyspnea 3 3
Unspecified Heart Problem 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 GE Healthcare (China) Co., Ltd. II Feb-28-2025
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 Medical Systems, LLC II Nov-22-2024
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 NEDERLAND B.V. II May-15-2025
18 Philips North America II Jun-09-2025
19 Philips North America II Feb-02-2024
20 Philips North America III Jan-25-2024
21 Philips North America II Aug-11-2023
22 Philips North America II Aug-11-2023
23 Philips North America Llc II May-16-2025
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
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