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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
3DIO
  SUBSTANTIALLY EQUIVALENT 1
ALLIAGE S/A INDUSTRIAS MÉDICO ODONTOLÓGICA
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DE GÖTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
NINGBO RUNYES MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSSTEM IMPLANT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XPECTVISION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURROUND MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
VSI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 21 21
2020 4 4
2021 4 4
2022 4 4
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 15 15
Device Operational Issue 5 5
Image Display Error/Artifact 2 2
Mechanical Problem 2 2
Detachment of Device or Device Component 2 2
Fire 1 1
Unintended System Motion 1 1
Overheating of Device 1 1
Device Slipped 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Insufficient Information 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Unintended Application Program Shut Down 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 16 16
No Clinical Signs, Symptoms or Conditions 6 6
Radiation Exposure, Unintended 5 5
No Known Impact Or Consequence To Patient 3 3
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Patient Problem/Medical Problem 1 1
Headache 1 1
Electric Shock 1 1

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