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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 GOTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DE GÖTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIGIMED CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012)
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ECOTRON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ENERGY RESOURCES INTERNATIONAL CO., LTD. HSINCHU BRANCH
  SUBSTANTIALLY EQUIVALENT 1
EXARO CO., LTD.
  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
HANJIN DIGI-X CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
IRAY TECHNOLOGY TAICANG LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
META BIOMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
MINXRAY, 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
OSSTEM IMPLANT CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
OWANDY
  SUBSTANTIALLY EQUIVALENT 1
PLANMECA OY
  SUBSTANTIALLY EQUIVALENT 1
RADIOTECNOLOGIA INDUSTRIAL S.A. DE C.V.
  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
  SUBSTANTIALLY EQUIVALENT 2
SKANRAY TECHNOLOGIES PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SURROUND MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TAKARA BELMONT CORP.
  SUBSTANTIALLY EQUIVALENT 1
TAKARA BELMONT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRIDENT S.R.L
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
VATECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VILLA SISTEMI MEDICALI S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
VSI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 20 20
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

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 95 95
Component Falling 52 52
Nonstandard Device 47 47
Migration or Expulsion of Device 37 37
Device Operational Issue 18 18
Installation-Related Problem 18 18
Noise, Audible 15 15
Detachment Of Device Component 12 12
Device Operates Differently Than Expected 10 10
Melted 9 9
Mechanical Problem 8 8
Break 7 7
Material Separation 7 7
Unintended Movement 7 7
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Device Dislodged or Dislocated 6 6
Insufficient Information 6 6
Thermal Decomposition of Device 6 6
Fracture 5 5
Overheating of Device 5 5
Device Slipped 5 5
Fire 4 4
Image Display Error/Artifact 3 3
Smoking 3 3
Device Emits Odor 3 3
Improper or Incorrect Procedure or Method 2 2
Device Maintenance Issue 2 2
Material Fragmentation 2 2
Crack 2 2
Device Handling Problem 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Power Problem 1 1
Radiation Overexposure 1 1
Temperature Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Misassembly by Users 1 1
Electrical Shorting 1 1
Failure of Device to Self-Test 1 1
Human Factors Issue 1 1
Improper Device Output 1 1
Device Fell 1 1
Unintended Electrical Shock 1 1
Radiation Output Problem 1 1
Unintended Application Program Shut Down 1 1
Material Discolored 1 1
Fluid/Blood Leak 1 1
Bent 1 1
Insufficient Heating 1 1
Hole In Material 1 1
Device Issue 1 1
Device Tipped Over 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Sticking 1 1
Unstable 1 1
Unintended Collision 1 1
Unintended System Motion 1 1
Inadequate Service 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 116 116
No Known Impact Or Consequence To Patient 93 93
Contusion 20 20
Injury 18 18
Radiation Exposure, Unintended 15 15
No Consequences Or Impact To Patient 14 14
Head Injury 12 12
No Clinical Signs, Symptoms or Conditions 6 6
No Information 5 5
Pain 5 5
Neck Pain 4 4
Laceration(s) 4 4
Electric Shock 4 4
Missing Value Reason 3 3
Bruise/Contusion 3 3
Abrasion 2 2
Bone Fracture(s) 2 2
Numbness 2 2
Loss of consciousness 2 2
No Code Available 2 2
Not Applicable 2 2
Patient Problem/Medical Problem 2 2
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Breast Mass 1 1
Suture Abrasion 1 1
Sprain 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Headache 1 1
Erythema 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aribex Inc II Sep-02-2016
2 CEFLA DENTAL GROUP II May-23-2013
3 Carestream Health Inc. II Mar-04-2014
4 Gendex Corp II Oct-02-2014
5 Gendex Dental Systems II Apr-02-2012
6 Gendex Dental Systems II Apr-22-2011
7 Gendex Dental Systems II Mar-04-2011
8 Gendex Dental Systems II Feb-18-2011
9 Gendex Dental Systems II Feb-15-2011
10 Instrumentarium Dental, PaloDEx Group Oy II Feb-25-2014
11 Panoramic Rental Corp. II Jan-09-2018
12 Panoramic Rental Corp. II Oct-04-2016
13 Panoramic Rental Corp. II Sep-01-2015
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