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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device unit, x-ray, extraoral with timer
Product CodeEHD
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
ARIBEX
  SUBSTANTIALLY EQUIVALENT 1
CEFLA SC
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGIMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ENERGY RESOURCES INTERNATIONAL CO., LTD. HSINCHU BRANCH
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDX WILL CORP.
  SUBSTANTIALLY EQUIVALENT 2
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
NANORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ROLENCE ENTERPRISE INC.
  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 2

MDR Year MDR Reports MDR Events
2017 66 66
2018 21 21
2019 21 21
2020 4 4
2021 4 4
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 69 69
Device Operational Issue 16 16
Unintended Movement 5 5
Migration or Expulsion of Device 5 5
Mechanical Problem 4 4
Insufficient Information 4 4
Break 3 3
Fire 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Maintenance Does Not Comply To Manufacturers Recommendations 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Power Problem 1 1
Radiation Overexposure 1 1
Temperature Problem 1 1
Electrical Shorting 1 1
Human Factors Issue 1 1
Device Handling Problem 1 1
Device Fell 1 1
Radiation Output Problem 1 1
Unintended Application Program Shut Down 1 1
Misassembly by Users 1 1
Bent 1 1
Device Maintenance Issue 1 1
Detachment Of Device Component 1 1
Material Discolored 1 1
Device Emits Odor 1 1
Unintended System Motion 1 1
Overheating of Device 1 1
Material Separation 1 1
Device Slipped 1 1
Unstable 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 79 79
Radiation Exposure, Unintended 14 14
No Known Impact Or Consequence To Patient 9 9
No Clinical Signs, Symptoms or Conditions 3 3
Abrasion 2 2
No Consequences Or Impact To Patient 2 2
Breast Mass 1 1
Suture Abrasion 1 1
Electric Shock 1 1
Bruise/Contusion 1 1
Erythema 1 1
Laceration(s) 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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