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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
ARIBEX
  SUBSTANTIALLY EQUIVALENT 1
CEFLA SC
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DE GÖTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012)
  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
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
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
RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
REMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ROLENCE ENTERPRISE INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XPECTVISION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SURROUND MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TRIDENT S.R.L
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
VSI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 110 110
2016 62 62
2017 66 66
2018 21 21
2019 21 21
2020 4 4
2021 4 4
2022 4 4
2023 2 2
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 95 95
Component Falling 49 49
Nonstandard Device 47 47
Migration or Expulsion of Device 37 37
Device Operational Issue 18 18
Installation-Related Problem 17 17
Noise, Audible 15 15
Mechanical Problem 8 8
Device Operates Differently Than Expected 8 8
Melted 8 8
Material Separation 7 7
Unintended Movement 7 7
Thermal Decomposition of Device 6 6
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Detachment Of Device Component 6 6
Device Dislodged or Dislocated 6 6
Overheating of Device 6 6
Break 5 5
Insufficient Information 5 5
Device Slipped 5 5
Fracture 4 4
Device Emits Odor 3 3
Fire 3 3
Detachment of Device or Device Component 2 2
Smoking 2 2
Defective Device 2 2
Improper or Incorrect Procedure or Method 2 2
Device Handling Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Maintenance Issue 2 2
Image Display Error/Artifact 2 2
Crack 2 2
Device Issue 1 1
Device Displays Incorrect Message 1 1
Unstable 1 1
Corroded 1 1
Radiation Output Problem 1 1
Improper Device Output 1 1
Sparking 1 1
Electrical /Electronic Property Problem 1 1
Device Fell 1 1
Unintended System Motion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure of Device to Self-Test 1 1
Therapeutic or Diagnostic Output Failure 1 1
Radiation Overexposure 1 1
Failure to Conduct 1 1
Power Problem 1 1
Unintended Collision 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 113 113
No Known Impact Or Consequence To Patient 79 79
Contusion 20 20
Injury 18 18
Radiation Exposure, Unintended 14 14
Head Injury 12 12
No Clinical Signs, Symptoms or Conditions 10 10
No Consequences Or Impact To Patient 10 10
No Information 5 5
Pain 5 5
Neck Pain 4 4
Laceration(s) 4 4
Electric Shock 3 3
Missing Value Reason 3 3
Bruise/Contusion 3 3
Patient Problem/Medical Problem 2 2
No Code Available 2 2
Not Applicable 2 2
Bone Fracture(s) 2 2
Abrasion 2 2
Numbness 2 2
Loss of consciousness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Complaint, Ill-Defined 1 1
Breast Mass 1 1
Sprain 1 1
Suture Abrasion 1 1
Discomfort 1 1
Erythema 1 1
Insufficient Information 1 1
Fall 1 1
Swelling/ Edema 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aribex Inc II Sep-02-2016
2 Panoramic Rental Corp. II Jan-09-2018
3 Panoramic Rental Corp. II Oct-04-2016
4 Panoramic Rental Corp. II Sep-01-2015
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