TPLC - Total Product Life Cycle

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Device	system, imaging, optical coherence tomography (oct)
Regulation Description	Ultrasonic pulsed echo imaging system.
Definition	This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Product Code	NQQ
Regulation Number	892.1560
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
DAMAE MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
GENTUITY, LLC
	SUBSTANTIALLY EQUIVALENT	1
LEADOPTIK, INC.
	SUBSTANTIALLY EQUIVALENT	1
OPXION TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	1
PERIMETER MEDICAL IMAGING AI, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN VIVOLIGHT MEDICAL DEVICE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRAWAVE, INC.
	SUBSTANTIALLY EQUIVALENT	5
TERUMO CARDIOVASCULAR SYSTEMS THI PLANT
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Computer Software Problem	4	4
Communication or Transmission Problem	2	2
Smoking	2	2
Failure to Power Up	2	2
Material Frayed	1	1
No Display/Image	1	1
Entrapment of Device	1	1
Unintended Electrical Shock	1	1
Difficult to Remove	1	1
Contamination /Decontamination Problem	1	1
Positioning Failure	1	1
Difficult or Delayed Activation	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Emits Odor	1	1
Material Separation	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Application Network Problem	1	1
Computer System Security Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
Electric Shock	3	3
Ventricular Fibrillation	1	1
No Consequences Or Impact To Patient	1	1
Device Embedded In Tissue or Plaque	1	1