Fujifilm Medical System U.S.A., Inc. - FDA 510(k) Cleared Devices
71
Total
71
Cleared
0
Denied
64 devices
Cleared
Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
Radiology
97d
Cleared
Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
Radiology
90d
Cleared
Oct 25, 2013
MAMMOGRAPHY VIEWER SMV658
Radiology
102d
Cleared
Jun 14, 2013
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Radiology
105d
Cleared
Apr 09, 2013
SYNAPSE 3D CARDIAC TOOLS
Radiology
54d
Cleared
Nov 20, 2012
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
Radiology
183d
Cleared
Nov 20, 2012
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
Radiology
99d
Cleared
Sep 21, 2012
ASPIRE HD PLUS, ASPIRE HD-S
Radiology
107d
Cleared
Aug 28, 2012
FDR GO FLEX
Radiology
180d
Cleared
Jul 05, 2012
SYNAPSE 3D CARDIAC TOOLS
Radiology
126d
Cleared
Jun 14, 2012
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
Radiology
104d
Cleared
Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
Radiology
60d
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