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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
ASPECT IMAGING, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 19
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
EYAS MEDICAL IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 1
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 8
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 1
HYPERFINE, INC.
  SUBSTANTIALLY EQUIVALENT 11
IMRIS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU LICI MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDIMAGEMETRIC, LLC
  SUBSTANTIALLY EQUIVALENT 1
MRI DIVISION,BEIJING WANDONG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
PERSPECTUM
  SUBSTANTIALLY EQUIVALENT 1
PERSPECTUM, LTD.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 9
PHILIPS MEDICAL SYSTEMS NEDERLANDS 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 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 11
SHANGHAI UNITED IMAGING INTELLIGENCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RF TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 20
SIEMENS SHENZHEN MAGNETIC RESONANCE , LTD.
  SUBSTANTIALLY EQUIVALENT 3
SINO CANADA HEALTH ENGINEERING RESEARCH INSTITUTE (HEFEI)
  SUBSTANTIALLY EQUIVALENT 1
SPINTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPRINGBOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPRINGBOK, INC. (DBA SPRINGBOK ANALYTICS)
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHETICMR AB
  SUBSTANTIALLY EQUIVALENT 1
SYNTHETICMR AB (PUBL.)
  SUBSTANTIALLY EQUIVALENT 2
TERRAN BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
TIME MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS A/S
  SUBSTANTIALLY EQUIVALENT 1
TRACINNOVATIONS APS
  SUBSTANTIALLY EQUIVALENT 1
VISTA AI, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 84 86
2022 138 142
2023 159 159
2024 281 281
2025 1278 1278
2026 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1290 1290
Insufficient Information 241 241
Improper or Incorrect Procedure or Method 155 155
Adverse Event Without Identified Device or Use Problem 124 125
Use of Device Problem 93 93
Device Handling Problem 36 36
Patient Device Interaction Problem 28 28
Excessive Heating 19 19
Patient-Device Incompatibility 12 16
No Apparent Adverse Event 11 11
Output Problem 9 9
Appropriate Term/Code Not Available 8 8
Unintended Movement 8 8
Device-Device Incompatibility 7 7
Temperature Problem 7 7
Electrical Overstress 7 7
Poor Quality Image 6 6
Misassembled During Installation 6 6
Mechanical Jam 5 5
Connection Problem 5 5
Defective Device 5 5
Sparking 4 4
Compatibility Problem 4 4
Noise, Audible 4 4
Device Emits Odor 4 4
Break 4 4
Protective Measures Problem 4 4
Electrical /Electronic Property Problem 4 4
Electromagnetic Interference 4 4
Installation-Related Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Unexpected Therapeutic Results 3 3
Therapeutic or Diagnostic Output Failure 3 3
Positioning Problem 3 3
Defective Component 3 3
Smoking 3 3
Unintended Electrical Shock 3 3
Overheating of Device 3 3
Arcing 3 3
Mechanical Problem 3 3
Fire 3 3
Unintended Collision 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Difficult to Advance 2 2
Melted 2 2
Collapse 2 2
Key or Button Unresponsive/not Working 2 2
Malposition of Device 2 2
Failure to Advance 2 2
Thermal Decomposition of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1383 1384
Partial thickness (Second Degree) Burn 97 98
Burn(s) 73 73
Full thickness (Third Degree) Burn 61 61
Superficial (First Degree) Burn 51 51
Bone Fracture(s) 49 49
Pain 48 52
Tinnitus 45 45
Laceration(s) 42 42
Insufficient Information 41 41
Burning Sensation 39 39
Blister 31 31
Hearing Impairment 23 23
Erythema 21 21
Partial Hearing Loss 16 16
Unspecified Tissue Injury 12 12
Discomfort 11 11
Headache 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Swelling/ Edema 9 11
Skin Burning Sensation 9 9
Rash 8 8
Muscle Weakness 7 7
Nausea 7 7
Bruise/Contusion 7 7
Radiation Burn 7 7
Limb Fracture 7 7
Multiple Fractures 7 7
Electric Shock 6 6
Sleep Dysfunction 6 6
Alteration in Body Temperature 6 6
Diaphoresis 5 5
Shaking/Tremors 5 6
Unspecified Musculoskeletal problem 5 5
Confusion/ Disorientation 5 5
Chest Pain 5 7
Blurred Vision 5 5
Hot Flashes/Flushes 4 5
Dizziness 4 4
Inflammation 4 5
Crushing Injury 4 4
Dyspnea 4 4
High Blood Pressure/ Hypertension 4 4
Eye Injury 4 4
Unspecified Ear or Labyrinth Problem 4 4
Neck Pain 4 4
Joint Dislocation 3 3
Anxiety 3 3
Distress 3 3
Brain Injury 3 4

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Jan-13-2026
2 Canon Medical System, USA, INC. II Oct-24-2025
3 Canon Medical System, USA, INC. II Jun-09-2024
4 Canon Medical System, USA, INC. II Mar-04-2024
5 Canon Medical System, USA, INC. II Jul-09-2021
6 GE Healthcare (China) Co., Ltd. II Feb-28-2025
7 GE Healthcare, LLC II Jul-21-2022
8 GE Healthcare, LLC II Apr-21-2022
9 GE Healthcare, LLC II Apr-04-2022
10 GE Healthcare, LLC II Feb-09-2022
11 GE Healthcare, LLC II Oct-16-2021
12 GE Healthcare, LLC II Jul-12-2021
13 GE Medical Systems, LLC II Aug-13-2025
14 GE Medical Systems, LLC II Jul-18-2025
15 GE Medical Systems, LLC II Nov-22-2024
16 GE Medical Systems, LLC II Aug-02-2024
17 Hitachi Healthcare Americas Corporation II Aug-24-2021
18 IMPRIS Imaging Inc I Oct-28-2025
19 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-15-2025
20 Philips North America II Jan-29-2026
21 Philips North America II Jul-30-2025
22 Philips North America II Jun-09-2025
23 Philips North America II Feb-02-2024
24 Philips North America III Jan-25-2024
25 Philips North America II Aug-11-2023
26 Philips North America II Aug-11-2023
27 Philips North America Llc II May-16-2025
28 Philips North America Llc II Sep-20-2024
29 Philips North America Llc II Jun-04-2024
30 Philips North America Llc II May-17-2024
31 Philips North America Llc II May-15-2024
32 Philips North America Llc II Apr-17-2024
33 Philips North America Llc I Dec-14-2023
34 Philips North America Llc II Nov-21-2023
35 Philips North America Llc II Dec-08-2022
36 Philips North America Llc II Sep-03-2021
37 Philips North America Llc II Aug-25-2021
38 Philips North America Llc II Jun-04-2021
39 Siemens Medical Solutions USA, Inc I Nov-12-2025
40 Siemens Medical Solutions USA, Inc I Sep-30-2025
41 Siemens Medical Solutions USA, Inc II Sep-29-2023
42 Siemens Medical Solutions USA, Inc II Sep-10-2021
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