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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cabinet, x-ray system
Product CodeMWP
Regulation Number 892.1680
Device Class 2


Premarket Reviews
ManufacturerDecision
CIRDAN IMAGING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
CIRDAN IMAGING LTD
  SUBSTANTIALLY EQUIVALENT 1
CLARIX IMAGING
  SUBSTANTIALLY EQUIVALENT 1
COMPAI HEALTHCARE (SHENZHEN) CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
COMPAI HEALTHCARE (SUZHOU) CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
FAXITRON BIOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
KUB TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2021 3 3
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 2 2
Application Program Version or Upgrade Problem 1 1
Inadequate User Interface 1 1
Inappropriate or Unexpected Reset 1 1
Operating System Version or Upgrade Problem 1 1
Computer Software Problem 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Laceration(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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