Fujifilm Medical Systems U.S.A, Inc. - FDA 510(k) Cleared Devices
39
Total
39
Cleared
0
Denied
26 devices
Cleared
Oct 27, 2017
ASPIRE Cristalle
Radiology
28d
Cleared
Sep 29, 2017
ASPIRE Bellus II
Radiology
134d
Cleared
Jun 30, 2017
Dynamic Visualization II Image Processing Option for the FDX Console...
Radiology
190d
Cleared
Apr 24, 2017
FDR AQRO (DR-XD 1000)
Radiology
33d
Cleared
Apr 06, 2017
Synapse 3D Perfusion Analysis
Radiology
234d
Cleared
Mar 16, 2017
FDX Console (DR-ID300CL) Software
Radiology
29d
Cleared
Apr 08, 2016
FDR D-EVO flat Panel Detector System
Radiology
129d
Cleared
Feb 03, 2016
Synapse PACS
Radiology
15d
Cleared
Aug 12, 2015
Synapse Cardiovascular
Radiology
35d
Cleared
Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
Radiology
94d
Cleared
Mar 25, 2014
ASPIRE CRISTALLE
Radiology
89d
Cleared
Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
Radiology
105d