FDA 510(k) Applications Submitted by FUJIFILM MEDICAL SYSTEM U.S.A., INC.

FDA 510(k) Number Submission Date Device Name Applicant
K122535 08/20/2012 FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K111646 06/13/2011 ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K101662 06/14/2010 SYNAPSE 3D BASIC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K101686 06/16/2010 FDR IMAGE STITCHING OPTION FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K111865 06/30/2011 WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K122454 08/13/2012 FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K093427 11/03/2009 FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K103687 12/17/2010 SYNAPSE 3D CEREBRAL ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K113244 11/02/2011 SYNAPSE MPR FUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K041990 07/23/2004 FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K042023 07/28/2004 FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K033377 10/22/2003 FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K033561 11/12/2003 FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K121035 04/05/2012 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K133976 12/26/2013 FUJIFILM ENDOSCOPIC CO2 REGULATOR FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K991257 04/13/1999 FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K013218 09/26/2001 FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K993861 11/15/1999 FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K130383 02/14/2013 SYNAPSE 3D CARDIAC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K120636 03/01/2012 SYNAPSE 3D CARDIAC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K120637 03/01/2012 SYNAPSE 3D BRAIN PERFUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K130542 03/01/2013 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K120648 03/02/2012 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K132188 07/15/2013 MAMMOGRAPHY VIEWER SMV658 FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K112439 08/24/2011 SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K110202 01/24/2011 FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K121499 05/21/2012 FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K111548 06/03/2011 WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K142003 07/23/2014 FDR D-EVO II FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K152138 07/31/2015 FDR D-EVO GL Flat Panel Detector System FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K110186 01/21/2011 SYNAPSE 3D LIVER ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K150221 01/30/2015 EPX-4440HD and EPX-4400HD with FICE FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K151474 06/01/2015 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K142629 09/16/2014 EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K120629 03/01/2012 FDR GO FLEX FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K100881 03/30/2010 SYNAPSE OBLIQUUS MIP/MPR/FUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K121674 06/06/2012 ASPIRE HD PLUS, ASPIRE HD-S FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K960326 01/24/1996 FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K970293 01/24/1997 FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K970349 01/30/1997 FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667 FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K972256 06/16/1997 FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS) FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K962967 07/30/1996 FUJI MEDICAL DRY IMAGER FM-DP 2636 FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K153206 11/05/2015 Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K163675 12/27/2016 Processor VP-7000, Light Source BL-7000 FUJIFILM Medical System U.S.A., Inc.


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