Fujifilm Medical System U.S.A., Inc.

FDA 510(k) & PMA Approved Devices — 66 products

Total Devices66

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Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K163675	Processor VP-7000, Light Source BL-7000	FET	2017-04-25	View
510(k)	K153206	Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1	FDS	2016-03-03	View
510(k)	K151474	Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)	KGE	2016-02-18	View
510(k)	K132188	MAMMOGRAPHY VIEWER SMV658	LLZ	2013-10-25	View
510(k)	K130542	SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS	LLZ	2013-06-14	View
510(k)	K130383	SYNAPSE 3D CARDIAC TOOLS	LLZ	2013-04-09	View
510(k)	K122535	FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H	EOQ	2012-12-13	View
510(k)	K121499	FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM	IZF	2012-11-20	View
510(k)	K122454	FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION	KPR	2012-11-20	View
510(k)	K121674	ASPIRE HD PLUS, ASPIRE HD-S	MUE	2012-09-21	View
510(k)	K120629	FDR GO FLEX	MQB	2012-08-28	View
510(k)	K120636	SYNAPSE 3D CARDIAC TOOLS	LLZ	2012-07-05	View
510(k)	K120648	SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS	LLZ	2012-06-14	View
510(k)	K121035	FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US	EOQ	2012-06-04	View
510(k)	K120637	SYNAPSE 3D BRAIN PERFUSION	LLZ	2012-05-08	View
510(k)	K113244	SYNAPSE MPR FUSION	LLZ	2011-12-22	View
510(k)	K111646	ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR	MUE	2011-12-08	View
510(k)	K112439	SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0	LLZ	2011-10-17	View
510(k)	K111865	WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE	MQB	2011-09-30	View
510(k)	K111548	WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE	MQB	2011-08-30	View