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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, extraoral with timer
Product CodeEHD
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
DENTERPRISE INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ECOTRON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ENERGY RESOURCES INTERNATIONAL CO., LTD. HSINCHU BRANCH
  SUBSTANTIALLY EQUIVALENT 1
FONA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
IRAY TECHNOLOGY TAICANG LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
NANORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ROLENCE ENTERPRISE INC.
  SUBSTANTIALLY EQUIVALENT 1
SURROUND MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TRIDENT S.R.L
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
VSI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 21 21
2019 21 21
2020 4 4
2021 4 4
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 22 22
Device Operational Issue 14 14
Mechanical Problem 3 3
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Unintended Movement 2 2
Insufficient Information 2 2
Device Fell 1 1
Unintended Electrical Shock 1 1
Radiation Output Problem 1 1
Unintended Application Program Shut Down 1 1
Electrical Shorting 1 1
Radiation Overexposure 1 1
Bent 1 1
Fire 1 1
Unintended System Motion 1 1
Overheating of Device 1 1
Material Separation 1 1
Device Slipped 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 25 25
Radiation Exposure, Unintended 13 13
No Known Impact Or Consequence To Patient 5 5
No Clinical Signs, Symptoms or Conditions 4 4
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Abrasion 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 1
Electric Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Panoramic Rental Corp. II Jan-09-2018
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