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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, extraoral source, digital
Regulation Description Extraoral source x-ray system.
Product CodeMUH
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
AIR TECHNIQUES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLIAGE S/A INDUSTRIAS MEDICA ODONTOLÓGICO.
  SUBSTANTIALLY EQUIVALENT 1
ATHLOS OY
  SUBSTANTIALLY EQUIVALENT 1
CND GLOBAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRUXELL CORP.
  SUBSTANTIALLY EQUIVALENT 2
DE GOTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DE GÖTZEN S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
DENTAL IMAGING TECHNOLOGIES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DENTERPRISE INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DENTIMAX, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEXCOWIN GLOBAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DURR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 2
DÜRR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 1
FONA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
FSUSEN TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HEFEI DENTAFILM MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IRAY IMAGING TECHNOLOGY (HAINING) LIMITED
  SUBSTANTIALLY EQUIVALENT 2
IRAY TECHNOLOGY TAICANG , LTD.
  SUBSTANTIALLY EQUIVALENT 3
JAZZ IMAGING, LLC DBA JAZZ IMAGING
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU DYNAMIC MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PICOPACK, INC.
  SUBSTANTIALLY EQUIVALENT 1
QPIX SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
RAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REALCLOUD IMAGING INC. DBA REALCLOUD IMAGING
  SUBSTANTIALLY EQUIVALENT 1
REMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROLENCE ENTERPRISE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN XPECTVISION TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOTA PRECISION OPTICS, INC. DBA SOTA IMAGING
  SUBSTANTIALLY EQUIVALENT 1
THE YOSHIDA DENTAL MFG. CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIDENT S.R.L
  SUBSTANTIALLY EQUIVALENT 1
TUXEDO IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZINNOVI, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2021 1 1
2023 1 1
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operational Issue 5 5
Patient-Device Incompatibility 2 2
Radiation Overexposure 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Radiation Exposure, Unintended 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Fatigue 1 1
Neck Pain 1 1
Cramp(s) 1 1
Eye Injury 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Headache 1 1
Loss of Vision 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 KaVo Dental Technologies LLC II May-21-2019
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