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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
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
2019 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Vibration 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Mar-18-2020
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