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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
  1.  K183624  Kubtec Mozart (Xpert42)
  2.  K200756  Kubtec Mozart Supra
  3.  K210955  Kubtec Mozart Supra (XPERT 84) Radiography System
  4.  K210956  Kubtec Mozart (XPERT42)
  5.  K210957  Kubec Xpert 80 Radiography System

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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