Fujifilm Medical System U S A Inc

FDA Filings

This page includes the latest FDA filings for Fujifilm Medical System U S A Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K163675 FUJIFILM Medical System U.S.A., Inc.	Processor VP-7000, Light Source BL-7000	2017-04-25
PMN K153206 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	Fujifilm Ultrasonic Processors SU-1 PLATINUM And SU-1	2016-03-03
PMN K151474 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)	2016-02-18
PMN K152138 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FDR D-EVO GL Flat Panel Detector System	2015-11-05
PMN K150221 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	EPX-4440HD And EPX-4400HD With FICE	2015-10-01
PMN K142629 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	EG-530CT, EG-530D, EC-530DL, And ES-530WE Endoscopes	2015-05-14
PMN K142003 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FDR D-EVO II FLAT PANEL DETECTOR SYSTEM	2014-10-21
PMN K133976 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJIFILM ENDOSCOPIC CO2 REGULATOR	2014-09-09
PMN K132188 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	MAMMOGRAPHY VIEWER SMV658	2013-10-25
PMN K130542 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS	2013-06-14
PMN K130383 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D CARDIAC TOOLS	2013-04-09
PMN K122535 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H	2012-12-13
PMN K122454 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION	2012-11-20
PMN K121499 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM	2012-11-20
PMN K121674 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	ASPIRE HD PLUS, ASPIRE HD-S	2012-09-21
PMN K120629 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FDR GO FLEX	2012-08-28
PMN K120636 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D CARDIAC TOOLS	2012-07-05
PMN K120648 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS	2012-06-14
PMN K121035 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US	2012-06-04
PMN K120637 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D BRAIN PERFUSION	2012-05-08
PMN K113244 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE MPR FUSION	2011-12-22
PMN K111646 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR	2011-12-08
PMN K112439 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0	2011-10-17
PMN K111865 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE	2011-09-30
PMN K111548 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE	2011-08-30
PMN K110186 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D LIVER ANALYSIS	2011-04-07
PMN K103687 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D CEREBRAL ANALYSIS	2011-03-04
PMN K110202 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB	2011-02-08
PMN K101686 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FDR IMAGE STITCHING OPTION	2010-10-29
PMN K101662 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE 3D BASIC TOOLS	2010-07-26
PMN K100881 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	SYNAPSE OBLIQUUS MIP/MPR/FUSION	2010-04-14
PMN K093427 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR	2010-01-21
PMN K042023 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER	2004-08-25
PMN K041990 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP	2004-08-06
PMN K033377 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L	2004-01-09
PMN K033561 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER	2003-11-26
PMN K013218 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II	2001-12-20
PMN K993861 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER	2000-02-10
PMN K991257 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION	1999-06-25
PMN K972256 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)	1997-09-12
PMN K970349 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667	1997-03-31
PMN K970293 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666	1997-03-21
PMN K962967 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI MEDICAL DRY IMAGER FM-DP 2636	1996-10-28
PMN K960326 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM	1996-03-07
PMN K951373 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ	1995-10-27
PMN K952862 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR	1995-09-20
PMN K950721 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L	1995-05-24
PMN K944046 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI COMPUTED RADIOGRAPHY SYSTEMS	1995-05-11
PMN K950610 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FIKO FO;, TJER,A; O,AGER FTO-1000	1995-04-25
PMN K945475 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI MEDICAL LASER IMAGER FL-IM D	1995-03-09
PMN K942561 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI FCR IMAGE PROCESSING UNIT IP-U515	1994-12-23
PMN K943823 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12	1994-08-22
PMN K943822 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI UM MAMMO SERIES INTENSIFY SCREENS:	1994-08-22
PMN K943821 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC	1994-08-22
PMN K943425 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI HG-M INTENSIFYING SCREEN	1994-08-17
PMN K942235 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	KYOKKO GREEN SERIES INTENSIFYING SCREENS	1994-08-17
PMN K942805 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	KYOKKO BLUE SERIES INTENSIFYING SCREENS	1994-07-29
PMN K942481 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI ULTIMA EC-MA CASSETTE	1994-07-29
PMN K942399 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	KYOKKO UM SERIES INTENSIFYING SCREEN	1994-06-10
PMN K935957 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI MEDICAL FILM PROCESSOR FPM2800	1994-01-31
PMN K933408 FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJI DAYLIGHT CASSETTE MULTI-LOADER	1993-08-16

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