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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, tomographic
Product CodeIZF
Regulation Number 892.1740
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENERAL MEDICAL MERATE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
NANO-X IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
PAUSCH MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 2 2
Loose or Intermittent Connection 1 1
Vibration 1 1
Defective Device 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Increased Sensitivity 1 1
Bone Fracture(s) 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Mar-18-2020
2 Philips Electronics North America Corporation II Sep-21-2018
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