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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 1
APOLLO MEDICAL OPTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENTUITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
NINEPOINT MEDICAL, INC
  SE - WITH LIMITATIONS 1
NINEPOINT MEDICAL, INC.
  SE - WITH LIMITATIONS 2
PERIMETER MEDICAL IMAGING AI, INC.
  SUBSTANTIALLY EQUIVALENT 1
PERIMETER MEDICAL IMAGING, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3 3
2018 4 4
2019 6 6
2020 4 4
2021 3 3
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment Of Device Component 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Communication or Transmission Problem 3 3
Poor Quality Image 2 2
Failure to Power Up 1 1
Smoking 1 1
Difficult or Delayed Activation 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1
Inadequate User Interface 1 1
Positioning Failure 1 1
Electrical /Electronic Property Problem 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Material Frayed 1 1
Mechanical Problem 1 1
Unintended Electrical Shock 1 1
Unexpected Shutdown 1 1
Thermal Decomposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 9 9
No Clinical Signs, Symptoms or Conditions 8 8
Laceration(s) of Esophagus 3 3
Patient Problem/Medical Problem 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 1 1
No Patient Involvement 1 1
Myocardial Infarction 1 1
Thrombus 1 1
Ventricular Fibrillation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ninepoint Medical Inc. II May-09-2018
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