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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Fujifilm Medical System U.S.A., Inc. · Predicate Candidate Screening

71 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time
206 days90th percentile
71clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc.2017-04-251190
K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc.2016-03-031190
K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic SlitterFujifilm Medical System U.S.A., Inc.2016-02-182620
K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc.2015-11-05970
K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc.2015-10-012440
K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc.2015-05-142400
K142003FDR D-EVO II FLAT PANEL DETECTOR SYSTEMFujifilm Medical System U.S.A., Inc.2014-10-21900
K133976FUJIFILM ENDOSCOPIC CO2 REGULATORFujifilm Medical System U.S.A., Inc.2014-09-092570
K132188MAMMOGRAPHY VIEWER SMV658Fujifilm Medical System U.S.A., Inc.2013-10-251020
K130542SYNAPSE 3D LUNG AND ABDOMEN ANALYSISFujifilm Medical System U.S.A., Inc.2013-06-141050
K130383SYNAPSE 3D CARDIAC TOOLSFujifilm Medical System U.S.A., Inc.2013-04-09540
K122535FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-53Fujifilm Medical System U.S.A., Inc.2012-12-131150
K121499FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY Fujifilm Medical System U.S.A., Inc.2012-11-201830
K122454FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTIONFujifilm Medical System U.S.A., Inc.2012-11-20990
K121674ASPIRE HD PLUS, ASPIRE HD-SFujifilm Medical System U.S.A., Inc.2012-09-211071
K120629FDR GO FLEXFujifilm Medical System U.S.A., Inc.2012-08-281800
K120636SYNAPSE 3D CARDIAC TOOLSFujifilm Medical System U.S.A., Inc.2012-07-051260
K120648SYNAPSE 3D LUNG AND ABDOMEN ANALYSISFujifilm Medical System U.S.A., Inc.2012-06-141040
K121035FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530USFujifilm Medical System U.S.A., Inc.2012-06-04600
K120637SYNAPSE 3D BRAIN PERFUSIONFujifilm Medical System U.S.A., Inc.2012-05-08680
K113244SYNAPSE MPR FUSIONFujifilm Medical System U.S.A., Inc.2011-12-22500
K111646ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READFujifilm Medical System U.S.A., Inc.2011-12-081780
K112439SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0Fujifilm Medical System U.S.A., Inc.2011-10-17540
K111865WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATUREFujifilm Medical System U.S.A., Inc.2011-09-30920
K111548WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DFujifilm Medical System U.S.A., Inc.2011-08-30880
K110186SYNAPSE 3D LIVER ANALYSISFujifilm Medical System U.S.A., Inc.2011-04-07760
K103687SYNAPSE 3D CEREBRAL ANALYSISFujifilm Medical System U.S.A., Inc.2011-03-04770
K110202FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CBFujifilm Medical System U.S.A., Inc.2011-02-08150
K101686FDR IMAGE STITCHING OPTIONFujifilm Medical System U.S.A., Inc.2010-10-291350
K101662SYNAPSE 3D BASIC TOOLSFujifilm Medical System U.S.A., Inc.2010-07-26420
K100881SYNAPSE OBLIQUUS MIP/MPR/FUSIONFujifilm Medical System U.S.A., Inc.2010-04-14150
K093427FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTORFujifilm Medical System U.S.A., Inc.2010-01-21790
K042023FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READERFujifilm Medical System U.S.A., Inc.2004-08-25280
K041990FUJI MEDICAL CR CONSOLE, MODEL FLASH IIPFujifilm Medical System U.S.A., Inc.2004-08-06140
K033377FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5Fujifilm Medical System U.S.A., Inc.2004-01-09790
K033561FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READERFujifilm Medical System U.S.A., Inc.2003-11-26140
K013218FUJI SPEED SUITE, FUJI SPEED SUTE PHASE IIFujifilm Medical System U.S.A., Inc.2001-12-20851
K993861FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READIFujifilm Medical System U.S.A., Inc.2000-02-10871
K991257FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSIONFujifilm Medical System U.S.A., Inc.1999-06-25731
K972256FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 Fujifilm Medical System U.S.A., Inc.1997-09-12880
K970349FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667Fujifilm Medical System U.S.A., Inc.1997-03-31600
K970293FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666Fujifilm Medical System U.S.A., Inc.1997-03-21560
K962967FUJI MEDICAL DRY IMAGER FM-DP 2636Fujifilm Medical System U.S.A., Inc.1996-10-28900
K960326FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MUFujifilm Medical System U.S.A., Inc.1996-03-07430
K951373FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQFujifilm Medical System U.S.A., Inc.1995-10-272140
K952862FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCRFujifilm Medical System U.S.A., Inc.1995-09-20900
K950721FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300LFujifilm Medical System U.S.A., Inc.1995-05-24970
K944046FUJI COMPUTED RADIOGRAPHY SYSTEMSFujifilm Medical System U.S.A., Inc.1995-05-112660
K950610FIKO FO;, TJER,A; O,AGER FTO-1000Fujifilm Medical System U.S.A., Inc.1995-04-25740
K945475FUJI MEDICAL LASER IMAGER FL-IM DFujifilm Medical System U.S.A., Inc.1995-03-091210

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda