FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

71 results for "Fujifilm Medical System U.S.A., Inc."
1–24 of 71
Search insights Median review: 83d Cleared: 100% Top manufacturer: Fujifilm Medical System U.S.A., Inc. Lead specialty: Radiology
Cleared Apr 25, 2017
Processor VP-7000, Light Source BL-7000
K163675 · FET
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 119d
Cleared Mar 03, 2016
Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
K153206 · FDS
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 119d
Cleared Feb 18, 2016
Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)
K151474 · KGE
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 262d
Cleared Nov 05, 2015
FDR D-EVO GL Flat Panel Detector System
K152138 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 97d
Cleared Oct 01, 2015
EPX-4440HD and EPX-4400HD with FICE
K150221 · FET
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 244d
Cleared May 14, 2015
EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes
K142629 · FDS
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 240d
Cleared Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K142003 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · FCX
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 257d
Cleared Oct 25, 2013
MAMMOGRAPHY VIEWER SMV658
K132188 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 102d
Cleared Jun 14, 2013
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K130542 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 105d
Cleared Apr 09, 2013
SYNAPSE 3D CARDIAC TOOLS
K130383 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 54d
Cleared Dec 13, 2012
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H
K122535 · EOQ
Fujifilm Medical System U.S.A., Inc.
Ear, Nose, Throat · 115d
Cleared Nov 20, 2012
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
K122454 · KPR
Fujifilm Medical System U.S.A., Inc.
Radiology · 99d
Cleared Nov 20, 2012
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
K121499 · IZF
Fujifilm Medical System U.S.A., Inc.
Radiology · 183d
Cleared Sep 21, 2012
ASPIRE HD PLUS, ASPIRE HD-S
K121674 · MUE
Fujifilm Medical System U.S.A., Inc.
Radiology · 107d
Cleared Aug 28, 2012
FDR GO FLEX
K120629 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 180d
Cleared Jul 05, 2012
SYNAPSE 3D CARDIAC TOOLS
K120636 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 126d
Cleared Jun 14, 2012
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K120648 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 104d
Cleared Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035 · EOQ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared May 08, 2012
SYNAPSE 3D BRAIN PERFUSION
K120637 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Dec 22, 2011
SYNAPSE MPR FUSION
K113244 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 50d
Cleared Dec 08, 2011
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM)
K111646 · MUE
Fujifilm Medical System U.S.A., Inc.
Radiology · 178d
Cleared Oct 17, 2011
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
K112439 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 54d
Cleared Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 92d