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TPLC
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show TPLC since
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Device
coil, magnetic resonance, specialty
Product Code
MOS
Regulation Number
892.1000
Device Class
2
Premarket Reviews
Manufacturer
Decision
GE HEALTHCARE
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE COILS (USA INSTRUMENTS, INC.)
SUBSTANTIALLY EQUIVALENT
4
INKSPACE IMAGING, INC.
SUBSTANTIALLY EQUIVALENT
1
INVIVO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
INVIVO CORPORATION (BUSINESS TRADE NAME: PHILIPS)
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
4
NORAS MRI PRODUCTS GMBH
SUBSTANTIALLY EQUIVALENT
3
NOVA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
SUBSTANTIALLY EQUIVALENT
1
QFIX
SUBSTANTIALLY EQUIVALENT
1
QUALITY ELECTRODYNAMICS, LLC
SUBSTANTIALLY EQUIVALENT
7
RAPID BIOMEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
3
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SHENZHEN RF TECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2017
9
9
2018
7
7
2019
8
8
2020
2
2
2021
2
2
2022
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
11
11
Improper or Incorrect Procedure or Method
3
3
Patient-Device Incompatibility
2
2
Temperature Problem
2
2
Insufficient Information
2
2
Device Operates Differently Than Expected
2
2
Device Unsafe to Use in Environment
1
1
Device Dislodged or Dislocated
1
1
Material Deformation
1
1
Device Fell
1
1
Excessive Heating
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
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
No Known Impact Or Consequence To Patient
5
5
Partial thickness (Second Degree) Burn
5
5
Burn, Thermal
4
4
Burn(s)
4
4
Erythema
3
3
Full thickness (Third Degree) Burn
3
3
Bone Fracture(s)
2
2
Itching Sensation
2
2
Rash
2
2
Swelling
2
2
Burning Sensation
2
2
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
Head Injury
1
1
Headache
1
1
No Information
1
1
No Code Available
1
1
No Clinical Signs, Symptoms or Conditions
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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