Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

72 results for "Fujifilm Medical System U.S.A., Inc."
1–24 of 72
Search insights Median review: 83d Cleared: 100% Top manufacturer: Fujifilm Medical System U.S.A., Inc. Lead specialty: Radiology
Cleared Jul 06, 2020
Fujifilm Ultrasonic Processor
K200850 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 97d
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