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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 20
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
ESAOTE, S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
EYAS MEDICAL IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  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 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 2
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 12
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 1279 1279
2026 221 221

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 1378 1378
Insufficient Device Problem Information 258 258
Improper or Incorrect Procedure or Method 153 153
Use of Device Problem 82 82
Adverse Event Without Identified Device or Use Problem 81 81
Device Handling Problem 39 39
Excessive Heating 14 14
Patient Device Interaction Problem 14 14
No Apparent Adverse Event 11 11
Appropriate Device Problem Term/Code Not Available 9 9
Electrical Overstress 7 7
Mechanical Jam 7 7
Misassembled During Installation 6 6
Temperature Problem 6 6
Activation Failure 5 5
Unexpected Shutdown 5 5
Sparking 5 5
Unintended Collision 4 4
Electrical /Electronic Property Problem 4 4
Use of Incorrect Control/Treatment Settings 4 4
Unintended Movement 4 4
Poor Quality Image 4 4
Product Quality Problem 3 3
Positioning Problem 3 3
Connection Problem 3 3
Installation-Related Problem 3 3
Unintended Electrical Shock 3 3
Arcing 3 3
Smoking 2 2
Mechanical Problem 2 2
Failure to Advance 2 2
Device-Device Incompatibility 2 2
Electromagnetic Compatibility Problem 2 2
Difficult to Advance 2 2
Patient-Device Incompatibility 2 2
Noise, Audible 2 2
Compatibility Problem 2 2
Device Unsafe to Use in Environment 2 2
Fire 2 2
Overheating of Device 2 2
Malposition of Device 2 2
Degraded 1 1
Inadequate or Insufficient Training 1 1
Migration 1 1
Break 1 1
Unintended System Motion 1 1
Inadequacy of Device Shape and/or Size 1 1
Material Integrity Problem 1 1
Loose or Intermittent Connection 1 1
No Display/Image 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1484 1485
Partial thickness (Second Degree) Burn 104 105
Burn(s) 80 80
Full thickness (Third Degree) Burn 63 63
Bone Fracture(s) 53 53
Superficial (First Degree) Burn 53 53
Pain 52 56
Insufficient Information 50 50
Tinnitus 49 49
Burning Sensation 44 44
Laceration(s) 43 43
Blister 31 31
Hearing Impairment 24 24
Erythema 23 23
Partial Hearing Loss 16 16
Discomfort 16 16
Skin Burning Sensation 13 13
Headache 13 13
Unspecified Tissue Injury 12 12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 12 12
Bruise/Contusion 10 10
Limb Fracture 9 9
Rash 9 9
Nausea 9 9
Swelling/ Edema 9 11
Alteration in Body Temperature 8 8
Radiation Burn 8 8
Multiple Fractures 7 7
Muscle Weakness/Atrophy 7 7
Electric Shock 6 6
Confusion/ Disorientation 6 6
Dizziness 6 6
Sleep Dysfunction 6 6
Diaphoresis 5 5
Ear Pain 5 5
Crushing Injury 5 5
Unspecified Musculoskeletal problem 5 5
Blurred Vision 5 5
Shaking/Tremors 5 6
Dyspnea 5 5
Chest Pain 5 7
Itching Sensation 5 5
Abrasion 4 4
Hypersensitivity/Allergic reaction 4 4
Emotional Changes 4 4
Neck Pain 4 4
Hot Flashes/Flushes 4 5
High Blood Pressure/ Hypertension 4 4
Anxiety 4 4
Ambulation or Postural Difficulties 4 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 Apr-02-2026
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 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 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-15-2025
21 Philips North America II Apr-27-2026
22 Philips North America II Jan-29-2026
23 Philips North America II Jul-30-2025
24 Philips North America II Jun-09-2025
25 Philips North America II Feb-02-2024
26 Philips North America III Jan-25-2024
27 Philips North America II Aug-11-2023
28 Philips North America II Aug-11-2023
29 Philips North America Llc II May-16-2025
30 Philips North America Llc II Sep-20-2024
31 Philips North America Llc II Jun-04-2024
32 Philips North America Llc II May-17-2024
33 Philips North America Llc II May-15-2024
34 Philips North America Llc II Apr-17-2024
35 Philips North America Llc I Dec-14-2023
36 Philips North America Llc II Nov-21-2023
37 Philips North America Llc II Dec-08-2022
38 Philips North America Llc II Sep-03-2021
39 Philips North America Llc II Aug-25-2021
40 Philips North America Llc II Jun-04-2021
41 Siemens Medical Solutions USA, Inc I Nov-12-2025
42 Siemens Medical Solutions USA, Inc I Sep-30-2025
43 Siemens Medical Solutions USA, Inc II Sep-29-2023
44 Siemens Medical Solutions USA, Inc II Sep-10-2021
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