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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 3
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 8
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 4
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
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 5
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 343 343

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 476 476
Insufficient Information 145 145
Improper or Incorrect Procedure or Method 141 141
Adverse Event Without Identified Device or Use Problem 135 135
Use of Device Problem 87 87
Device Handling Problem 20 20
Patient Device Interaction Problem 16 16
Patient-Device Incompatibility 16 16
No Apparent Adverse Event 14 14
Excessive Heating 12 12
Electromagnetic Interference 9 9
Fire 8 8
Electrical Overstress 7 7
Device-Device Incompatibility 6 6
Temperature Problem 6 6
Misassembled During Installation 6 6
Overheating of Device 6 6
Appropriate Term/Code Not Available 6 6
Output Problem 6 6
Poor Quality Image 5 5
Connection Problem 5 5
Device Emits Odor 5 5
Break 5 5
Mechanical Jam 5 5
Defective Device 5 5
Smoking 5 5
Arcing 4 4
Noise, Audible 4 4
Protective Measures Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Device Unsafe to Use in Environment 3 3
Unintended Electrical Shock 3 3
Melted 3 3
Inadequacy of Device Shape and/or Size 3 3
Electromagnetic Compatibility Problem 3 3
Unintended Collision 3 3
Electrical /Electronic Property Problem 3 3
Unexpected Therapeutic Results 3 3
Positioning Problem 3 3
Thermal Decomposition of Device 3 3
Unexpected Shutdown 2 2
Collapse 2 2
Defective Component 2 2
Computer Software Problem 2 2
Compatibility Problem 2 2
Mechanical Problem 2 2
Malposition of Device 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Inadequate User Interface 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 557 557
Partial thickness (Second Degree) Burn 79 79
Burn(s) 48 48
Full thickness (Third Degree) Burn 47 47
Bone Fracture(s) 47 47
Pain 45 45
Tinnitus 43 43
Laceration(s) 37 37
Superficial (First Degree) Burn 36 36
Burning Sensation 33 33
Hearing Impairment 25 25
Blister 25 25
Insufficient Information 24 24
Erythema 16 16
Partial Hearing Loss 14 14
Patient Problem/Medical Problem 13 13
Headache 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Burn, Thermal 11 11
Unspecified Tissue Injury 11 11
No Known Impact Or Consequence To Patient 10 10
Injury 10 10
Skin Burning Sensation 9 9
Multiple Fractures 9 9
Discomfort 7 7
Rash 6 6
Unspecified Musculoskeletal problem 5 5
No Patient Involvement 5 5
Electric Shock 4 4
Sleep Dysfunction 4 4
Radiation Burn 4 4
Cardiac Arrest 4 4
Nausea 4 4
Ambulation Difficulties 4 4
Unspecified Ear or Labyrinth Problem 4 4
Swelling/ Edema 4 4
Alteration in Body Temperature 3 3
Unspecified Heart Problem 3 3
Numbness 3 3
Blurred Vision 3 3
Head Injury 3 3
Implant Pain 3 3
Neck Pain 3 3
Limb Fracture 3 3
Skin Irritation 3 3
Eye Injury 3 3
Emotional Changes 3 3
Ulcer 3 3
Failure of Implant 3 3
Misdiagnosis 2 2

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, LLC II Jul-21-2022
5 GE Healthcare, LLC II Apr-21-2022
6 GE Healthcare, LLC II Apr-04-2022
7 GE Healthcare, LLC II Feb-09-2022
8 GE Healthcare, LLC II Oct-16-2021
9 GE Healthcare, LLC II Jul-12-2021
10 GE Healthcare, LLC II Oct-20-2020
11 GE Healthcare, LLC II Jan-28-2020
12 GE Medical Systems, LLC II Nov-22-2024
13 GE Medical Systems, LLC II Aug-02-2024
14 Hitachi Healthcare Americas Corporation II Aug-24-2021
15 Invivo Corporation II Mar-04-2020
16 Philips North America II Feb-02-2024
17 Philips North America III Jan-25-2024
18 Philips North America II Aug-11-2023
19 Philips North America II Aug-11-2023
20 Philips North America Llc II Sep-20-2024
21 Philips North America Llc II Jun-04-2024
22 Philips North America Llc II May-17-2024
23 Philips North America Llc II May-15-2024
24 Philips North America Llc II Apr-17-2024
25 Philips North America Llc I Dec-14-2023
26 Philips North America Llc II Nov-21-2023
27 Philips North America Llc II Dec-08-2022
28 Philips North America Llc II Sep-03-2021
29 Philips North America Llc II Aug-25-2021
30 Philips North America Llc II Jun-04-2021
31 Siemens Medical Solutions USA, Inc II Sep-29-2023
32 Siemens Medical Solutions USA, Inc II Sep-10-2021
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