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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, imaging, optical coherence tomography (oct)
Definition This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Product CodeNQQ
Regulation Number 892.1560
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
APOLLO MEDICAL OPTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DAMAE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GENTUITY, LLC
  SUBSTANTIALLY EQUIVALENT 2
NINEPOINT MEDICAL, INC
  SE - WITH LIMITATIONS 1
PERIMETER MEDICAL IMAGING AI, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERIMETER MEDICAL IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRAWAVE INC
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 4 4
2021 3 3
2022 4 4
2023 6 6
2024 6 6

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 3 3
Poor Quality Image 2 2
Unintended Electrical Shock 2 2
Smoking 2 2
Failure to Power Up 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Frayed 1 1
Unexpected Shutdown 1 1
No Display/Image 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Positioning Failure 1 1
Difficult or Delayed Activation 1 1
Thermal Decomposition of Device 1 1
Material Separation 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Application Network Problem 1 1
Connection 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 17 17
No Consequences Or Impact To Patient 7 7
Electric Shock 3 3
Patient Problem/Medical Problem 2 2
Laceration(s) of Esophagus 1 1
No Patient Involvement 1 1
Thrombus 1 1
Device Embedded In Tissue or Plaque 1 1

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