FDA 510(k) Applications Submitted by FUJIFILM Medical Systems U.S.A., Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K152257 08/10/2015 Fujifilm Duodenoscope Model ED-530XT FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K153483 12/03/2015 Balloon controller PB-30 FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K100762 03/17/2010 FLAT PANEL DETECTOR, MODEL FDR D-EVO FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K070920 04/02/2007 FUJI IP CASSETTE TYPE PC FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K080945 04/03/2008 FCR GO PORTABLE DIGITAL X-RAY SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K103465 11/24/2010 SYNAPSE 3D CARDIAC TOOLS FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K081308 05/09/2008 FUJIFILM FCR VIEW, MODEL CR-VW674 FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K163624 12/22/2016 Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) FUJIFILM Medical Systems U.S.A., Inc.
K132210 07/16/2013 FUJIFILM 600 SERIES ENDOSCOPES FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K171096 04/13/2017 Fujifilm Diathermic Slitter (FlushKnife) FUJIFILM Medical Systems U.S.A., Inc.
K171207 04/25/2017 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M FUJIFILM Medical Systems U.S.A., Inc.
K160108 01/19/2016 Synapse PACS FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K120679 03/06/2012 SYNAPSE 3D NODULE ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K171463 05/18/2017 ASPIRE Bellus II FUJIFILM Medical Systems U.S.A., Inc.
K151859 07/08/2015 Synapse Cardiovascular FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K162287 08/15/2016 Synapse 3D Perfusion Analysis FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K173132 09/29/2017 ASPIRE Cristalle Fujifilm Medical Systems U.S.A., Inc.
K123566 11/20/2012 SYNAPSE 3D COLON ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K141765 07/01/2014 FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K103596 12/08/2010 WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K153464 12/01/2015 FDR D-EVO flat Panel Detector System FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K103720 12/21/2010 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K143556 12/15/2014 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K143732 12/29/2014 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Medical Systems U.S.A., Inc.
K140149 01/22/2014 EPX-4440HD DIGITAL VIDEO PROCESSOR FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K170451 02/15/2017 FDX Console (DR-ID300CL) Software FUJIFILM Medical Systems U.S.A., Inc.
K170858 03/22/2017 FDR AQRO (DR-XD 1000) FUJIFILM Medical Systems U.S.A., Inc.
K160196 01/27/2016 Fujifilm Video Colonoscope Model EC-600WL V2 FUJIFILM Medical Systems U.S.A., Inc.
K161186 04/27/2016 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K162622 09/20/2016 Fujifilm Endoscope Models EC-600HL and EC-600LS FUJIFILM Medical Systems U.S.A., Inc.
K171291 05/02/2017 FUJIFILM Bronchoscope Model EB-530P FUJIFILM Medical Systems U.S.A., Inc.
K162749 09/30/2016 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR FUJIFILM Medical Systems U.S.A., Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact