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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 coil, magnetic resonance, specialty
Regulation Description Magnetic resonance diagnostic device.
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 4
HITACHI MEDICAL SYSTEMS AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
INVIVO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
INVIVO CORPORATION (BUSINESS TRADE NAME: PHILIPS)
  SUBSTANTIALLY EQUIVALENT 1
INVIVO THERAPEUTICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LMT MEDICAL SYSTEMS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MORAS MRI PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
MR INSTRUMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
NEOCOIL, LLC
  SUBSTANTIALLY EQUIVALENT 3
NORAS MRI PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
NOVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QFIX
  SUBSTANTIALLY EQUIVALENT 1
QUALITY ELECTRODYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 12
RAPID BIOMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN RF TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 7 7
2017 9 9
2018 7 7
2019 8 8
2020 2 2
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11 11
Insufficient Information 4 4
Improper or Incorrect Procedure or Method 4 4
Patient-Device Incompatibility 2 2
Device Operates Differently Than Expected 2 2
Device Unsafe to Use in Environment 1 1
Device Dislodged or Dislocated 1 1
Failure of Device to Self-Test 1 1
Material Deformation 1 1
Device Fell 1 1
Excessive Heating 1 1
Temperature Problem 1 1
Communication or Transmission Problem 1 1
Detachment of Device or Device Component 1 1
Structural Problem 1 1
Defective Device 1 1
Break 1 1
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1
Image Resolution Poor 1 1
Nonstandard Device 1 1
Overheating of Device 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 6 6
No Known Impact Or Consequence To Patient 5 5
Burn, Thermal 4 4
Burning Sensation 4 4
Burn(s) 4 4
Erythema 3 3
Full thickness (Third Degree) Burn 3 3
No Information 2 2
Bone Fracture(s) 2 2
Itching Sensation 2 2
Rash 2 2
Swelling 2 2
Tinnitus 1 1
Tissue Damage 1 1
Tingling 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Injury 1 1
Reaction 1 1
Sweating 1 1
Skin Discoloration 1 1
Nerve Damage 1 1
Pain 1 1
Headache 1 1
Hearing Loss 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC II Oct-07-2019
2 Invivo Corporation III Oct-20-2020
3 Invivo Corporation II Aug-30-2016
4 NeoCoil, LLC II Aug-01-2016
5 NeoCoil, LLC II Feb-29-2016
6 Quality Electrodynamics LLC II Oct-03-2019
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