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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
Regulation Description Extraoral source x-ray system.
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 3
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 2
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
IRAY TECHNOLOGY TAICANG , LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUCAS LIFECARE
  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
PICOPACK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAYPIA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REMEDI 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
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 16 16
Device Operational Issue 5 5
Mechanical Problem 2 2
Image Display Error/Artifact 2 2
Defective Device 2 2
Detachment of Device or Device Component 2 2
Failure to Conduct 2 2
Overheating of Device 2 2
Corroded 2 2
Electrical /Electronic Property Problem 2 2
Circuit Failure 1 1
Device Slipped 1 1
Fire 1 1
Output Problem 1 1
Unintended Electrical Shock 1 1
Insufficient Information 1 1
Device Fell 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Application Program Shut Down 1 1
Product Quality Problem 1 1
Electrical Shorting 1 1
Device Dislodged or Dislocated 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 16 16
No Clinical Signs, Symptoms or Conditions 11 11
Radiation Exposure, Unintended 5 5
No Known Impact Or Consequence To Patient 3 3
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Electric Shock 1 1
Insufficient Information 1 1
Swelling/ Edema 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DIGIMED CO., LTD II Jul-18-2025
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