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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, x-ray, intraoral
Product CodeEAP
Regulation Number 872.1810
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED IMAGE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
HUMANRAY CO,LTD
  SUBSTANTIALLY EQUIVALENT 1
SCHICK TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 5 5
2019 3 3
2021 1 1
2022 2 2
2023 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Image Display Error/Artifact 12 12
Detachment of Device or Device Component 4 4
Device Operational Issue 2 2
Detachment Of Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
Structural Problem 1 1
Break 1 1
Loose or Intermittent Connection 1 1
Material Separation 1 1
Device Dislodged or Dislocated 1 1
Installation-Related Problem 1 1
Material Twisted/Bent 1 1
Output Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 2 2
Radiation Exposure, Unintended 1 1
No Information 1 1
Nerve Damage 1 1
Pain 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Chicago X-Ray Systems, Inc. II May-21-2013
2 DeGotzen II Apr-17-2013
3 Trophy Sas II May-02-2013
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