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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
Product CodeMUH
Regulation Number 872.1800
Device Class 2


Premarket Reviews
ManufacturerDecision
ALLIAGE S/A INDUSTRIAS MEDICA ODONTOLÓGICO.
  SUBSTANTIALLY EQUIVALENT 1
ATHLOS OY
  SUBSTANTIALLY EQUIVALENT 1
CRUXELL CORP.
  SUBSTANTIALLY EQUIVALENT 1
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 1
DURR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 2
DÜRR DENTAL SE
  SUBSTANTIALLY EQUIVALENT 1
FONA S.R.L
  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 1
QPIX SOLUTIONS INC.
  SUBSTANTIALLY EQUIVALENT 1
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
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
2021 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Fatigue 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Cancer 1 1

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