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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device coil, magnetic resonance, specialty
Product CodeMOS
Regulation Number 892.1000
Device Class 2


Premarket Reviews
ManufacturerDecision
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE COILS (USA INSTRUMENTS, INC.)
  SUBSTANTIALLY EQUIVALENT 3
INKSPACE IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 2
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION (BUSINESS TRADE NAME: PHILIPS)
  SUBSTANTIALLY EQUIVALENT 5
NEOCOIL, LLC
  SUBSTANTIALLY EQUIVALENT 4
NORAS MRI PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 3
NOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
POLAREAN, INC.
  SUBSTANTIALLY EQUIVALENT 1
QFIX
  SUBSTANTIALLY EQUIVALENT 1
QUALITY ELECTRODYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 6
RAPID BIOMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 4
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RF TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 7 7
2019 8 8
2020 2 2
2021 2 2
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Improper or Incorrect Procedure or Method 3 3
Insufficient Information 2 2
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 1 1
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Break 1 1
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1
Intermittent Continuity 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Device Fell 1 1
Excessive Heating 1 1
Structural Problem 1 1
Defective Device 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Partial thickness (Second Degree) Burn 4 4
Burn, Thermal 4 4
No Clinical Signs, Symptoms or Conditions 2 2
Itching Sensation 2 2
Burn(s) 2 2
Erythema 2 2
Bone Fracture(s) 2 2
Burning Sensation 2 2
Tingling 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Reaction 1 1
Sweating 1 1
Head Injury 1 1
Headache 1 1
Pain 1 1
Full thickness (Third Degree) Burn 1 1
Multiple Fractures 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Oct-07-2019
2 Invivo Corporation III Oct-20-2020
3 Quality Electrodynamics LLC II Oct-03-2019
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