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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 25
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
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 3
GE HEALTHCARE (TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 4
GE HEALTHCARE(TIANJIN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 6
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
IMRIS IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 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
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 10
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 HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 19
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 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
VISTA AI, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 98 99
2021 84 86
2022 138 141
2023 159 159
2024 281 281
2025 1180 1180

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1177 1177
Insufficient Information 212 212
Improper or Incorrect Procedure or Method 164 164
Adverse Event Without Identified Device or Use Problem 155 155
Use of Device Problem 106 106
Device Handling Problem 27 27
Patient Device Interaction Problem 23 23
Excessive Heating 17 17
Patient-Device Incompatibility 16 20
No Apparent Adverse Event 15 15
Electromagnetic Interference 9 9
Fire 8 8
Unintended Movement 8 8
Output Problem 7 7
Electrical Overstress 7 7
Device-Device Incompatibility 6 6
Temperature Problem 6 6
Misassembled During Installation 6 6
Overheating of Device 6 7
Connection Problem 6 6
Defective Device 6 6
Appropriate Term/Code Not Available 6 6
Mechanical Jam 5 5
Device Emits Odor 5 5
Break 5 5
Poor Quality Image 5 5
Smoking 5 5
Therapeutic or Diagnostic Output Failure 4 4
Protective Measures Problem 4 4
Electrical /Electronic Property Problem 4 4
Arcing 4 4
Noise, Audible 4 4
Defective Component 3 3
Unintended Electrical Shock 3 3
Melted 3 3
Positioning Problem 3 3
Unexpected Therapeutic Results 3 3
Mechanical Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Electromagnetic Compatibility Problem 3 3
Device Unsafe to Use in Environment 3 3
Unintended Collision 3 3
Compatibility Problem 3 3
Thermal Decomposition of Device 3 3
Computer Software Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Inadequate User Interface 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Key or Button Unresponsive/not Working 2 2
Unexpected Shutdown 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1272 1273
Partial thickness (Second Degree) Burn 97 98
Burn(s) 72 72
Full thickness (Third Degree) Burn 66 66
Pain 54 57
Bone Fracture(s) 53 53
Superficial (First Degree) Burn 48 48
Tinnitus 47 47
Laceration(s) 44 44
Burning Sensation 40 40
Insufficient Information 32 32
Blister 30 30
Hearing Impairment 26 26
Erythema 20 20
Partial Hearing Loss 17 17
Patient Problem/Medical Problem 13 13
Headache 13 13
Unspecified Tissue Injury 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Burn, Thermal 11 11
Skin Burning Sensation 10 10
No Known Impact Or Consequence To Patient 10 10
Injury 10 10
Discomfort 10 10
Multiple Fractures 9 9
Swelling/ Edema 8 10
Rash 7 7
Nausea 7 8
Sleep Dysfunction 6 6
Radiation Burn 6 6
Confusion/ Disorientation 5 5
Muscle Weakness 5 5
No Patient Involvement 5 5
Unspecified Musculoskeletal problem 5 5
Dizziness 5 6
Shaking/Tremors 5 6
Electric Shock 5 5
Bruise/Contusion 5 5
Ambulation Difficulties 5 5
High Blood Pressure/ Hypertension 5 5
Alteration in Body Temperature 4 4
Head Injury 4 4
Limb Fracture 4 4
Vomiting 4 5
Blurred Vision 4 4
Neck Pain 4 4
Hot Flashes/Flushes 4 4
Unspecified Ear or Labyrinth Problem 4 4
Cardiac Arrest 4 5
Unspecified Eye / Vision Problem 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Oct-24-2025
2 Canon Medical System, USA, INC. II Jun-09-2024
3 Canon Medical System, USA, INC. II Mar-04-2024
4 Canon Medical System, USA, INC. II Jul-09-2021
5 GE Healthcare (China) Co., Ltd. II Feb-28-2025
6 GE Healthcare, LLC II Jul-21-2022
7 GE Healthcare, LLC II Apr-21-2022
8 GE Healthcare, LLC II Apr-04-2022
9 GE Healthcare, LLC II Feb-09-2022
10 GE Healthcare, LLC II Oct-16-2021
11 GE Healthcare, LLC II Jul-12-2021
12 GE Healthcare, LLC II Oct-20-2020
13 GE Healthcare, LLC II Jan-28-2020
14 GE Medical Systems, LLC II Aug-13-2025
15 GE Medical Systems, LLC II Jul-18-2025
16 GE Medical Systems, LLC II Nov-22-2024
17 GE Medical Systems, LLC II Aug-02-2024
18 Hitachi Healthcare Americas Corporation II Aug-24-2021
19 IMPRIS Imaging Inc I Oct-28-2025
20 Invivo Corporation II Mar-04-2020
21 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-15-2025
22 Philips North America II Jul-30-2025
23 Philips North America II Jun-09-2025
24 Philips North America II Feb-02-2024
25 Philips North America III Jan-25-2024
26 Philips North America II Aug-11-2023
27 Philips North America II Aug-11-2023
28 Philips North America Llc II May-16-2025
29 Philips North America Llc II Sep-20-2024
30 Philips North America Llc II Jun-04-2024
31 Philips North America Llc II May-17-2024
32 Philips North America Llc II May-15-2024
33 Philips North America Llc II Apr-17-2024
34 Philips North America Llc I Dec-14-2023
35 Philips North America Llc II Nov-21-2023
36 Philips North America Llc II Dec-08-2022
37 Philips North America Llc II Sep-03-2021
38 Philips North America Llc II Aug-25-2021
39 Philips North America Llc II Jun-04-2021
40 Siemens Medical Solutions USA, Inc I Nov-12-2025
41 Siemens Medical Solutions USA, Inc I Sep-30-2025
42 Siemens Medical Solutions USA, Inc II Sep-29-2023
43 Siemens Medical Solutions USA, Inc II Sep-10-2021
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