TPLC - Total Product Life Cycle

show TPLC since

Device	system, radiation therapy, radionuclide
Product Code	IWB
Regulation Number	892.5750
Device Class	2

Premarket Reviews
Manufacturer	Decision
AKESIS INC
	SUBSTANTIALLY EQUIVALENT	3
BEST THERATRONICS LIMITED
	SUBSTANTIALLY EQUIVALENT	2
ELEKTA INSTRUMENT AB
	SUBSTANTIALLY EQUIVALENT	8
ELEKTA SOLUTIONS AB
	SUBSTANTIALLY EQUIVALENT	2
HYPER TECHNOLOGY INC
	SUBSTANTIALLY EQUIVALENT	1
MASEP MEDICAL SCIENCE & TECH.DEVELOPMENT (SHENZHEN
	SUBSTANTIALLY EQUIVALENT	1
OUR UNITED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
XCISION MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	7	7
Device Operates Differently Than Expected	6	6
Break	4	4
Positioning Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Misassembled	3	3
Insufficient Information	2	2
Electrical /Electronic Property Problem	2	2
Detachment Of Device Component	2	2
Disconnection	1	1
Fitting Problem	1	1
Off-Label Use	1	1
Malposition of Device	1	1
Application Program Problem	1	1
Device Fell	1	1
Therapeutic or Diagnostic Output Failure	1	1
Problem with Software Installation	1	1
Human Factors Issue	1	1
Device Maintenance Issue	1	1
Mechanics Altered	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Jam	1	1
Therapy Delivered to Incorrect Body Area	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	13	13
No Patient Involvement	8	8
No Consequences Or Impact To Patient	3	3
Not Applicable	2	2
No Code Available	2	2
No Information	2	2
Death	1	1
Tingling	1	1
Seizures	1	1
Radiation Exposure, Unintended	1	1
Memory Loss/Impairment	1	1
Necrosis	1	1
Disability	1	1
Cognitive Changes	1	1
Neurological Deficit/Dysfunction	1	1
Rash	1	1
Erythema	1	1
Pain	1	1
Blurred Vision	1	1
Loss of Vision	1	1
Cancer	1	1