TPLC - Total Product Life Cycle

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Device	coil, magnetic resonance, specialty
Regulation Description	Magnetic resonance diagnostic device.
Product Code	MOS
Regulation Number	892.1000
Device Class	2

Premarket Reviews
Manufacturer	Decision
DXTX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE COILS (USA INSTRUMENTS, INC.)
	SUBSTANTIALLY EQUIVALENT	2
INKSPACE IMAGING, INC.
	SUBSTANTIALLY EQUIVALENT	5
INSIGHT MEDBOTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INVIVO CORPORATION (BUSINESS TRADE NAME: PHILIPS)
	SUBSTANTIALLY EQUIVALENT	6
NEOCOIL, LLC
	SUBSTANTIALLY EQUIVALENT	2
NORAS MRI PRODUCTS GMBH
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDICAL SYSTEM NEDERLANDS B.V.
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
	SUBSTANTIALLY EQUIVALENT	4
POLAREAN, INC.
	SUBSTANTIALLY EQUIVALENT	3
QUALITY ELECTRODYNAMICS
	SUBSTANTIALLY EQUIVALENT	3
QUALITY ELECTRODYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
RAPID BIOMEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN RF TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	7	7
Improper or Incorrect Procedure or Method	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Electrical /Electronic Property Problem	2	2
Use of Device Problem	1	1
Defective Component	1	1
Temperature Problem	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Excessive Heating	1	1
Loose or Intermittent Connection	1	1
Break	1	1
Intermittent Continuity	1	1
Use of Incorrect Control/Treatment Settings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Partial thickness (Second Degree) Burn	7	7
Superficial (First Degree) Burn	5	5
No Clinical Signs, Symptoms or Conditions	2	2
Laceration(s)	2	2
Bone Fracture(s)	1	1
Head Injury	1	1
Multiple Fractures	1	1
Blister	1	1
Rash	1	1
Burning Sensation	1	1
Burn(s)	1	1
Erythema	1	1
Full thickness (Third Degree) Burn	1	1