Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
system, x-ray, tomographic
Product Code
IZF
Regulation Number
892.1740
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
-
-