Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Fujifilm Medical Systems U.S.A, Inc. · Predicate Candidate Screening
39 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
258 days90th percentile
39clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171291 | FUJIFILM Bronchoscope Model EB-530P | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-19 | 262 | 0 |
| K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-11 | 261 | 0 |
| K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 | 28 | 0 |
| K171463 | ASPIRE Bellus II | Fujifilm Medical Systems U.S.A, Inc. | 2017-09-29 | 134 | 0 |
| K152257 | Fujifilm Duodenoscope Model ED-530XT | Fujifilm Medical Systems U.S.A, Inc. | 2017-07-21 | 711 | 0 |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-30 | 190 | 0 |
| K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR | Fujifilm Medical Systems U.S.A, Inc. | 2017-06-15 | 258 | 0 |
| K171096 | Fujifilm Diathermic Slitter (FlushKnife) | Fujifilm Medical Systems U.S.A, Inc. | 2017-05-09 | 26 | 0 |
| K170858 | FDR AQRO (DR-XD 1000) | Fujifilm Medical Systems U.S.A, Inc. | 2017-04-24 | 33 | 2 |
| K162287 | Synapse 3D Perfusion Analysis | Fujifilm Medical Systems U.S.A, Inc. | 2017-04-06 | 234 | 0 |
| K170451 | FDX Console (DR-ID300CL) Software | Fujifilm Medical Systems U.S.A, Inc. | 2017-03-16 | 29 | 0 |
| K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | 2016-10-18 | 28 | 0 |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermi | Fujifilm Medical Systems U.S.A, Inc. | 2016-06-29 | 63 | 0 |
| K153464 | FDR D-EVO flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2016-04-08 | 129 | 0 |
| K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-23 | 27 | 0 |
| K160108 | Synapse PACS | Fujifilm Medical Systems U.S.A, Inc. | 2016-02-03 | 15 | 1 |
| K153483 | Balloon controller PB-30 | Fujifilm Medical Systems U.S.A, Inc. | 2015-12-15 | 12 | 0 |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580 | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-20 | 248 | 0 |
| K151859 | Synapse Cardiovascular | Fujifilm Medical Systems U.S.A, Inc. | 2015-08-12 | 35 | 1 |
| K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS | Fujifilm Medical Systems U.S.A, Inc. | 2015-07-06 | 189 | 0 |
| K141765 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2014-10-03 | 94 | 0 |
| K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR | Fujifilm Medical Systems U.S.A, Inc. | 2014-08-22 | 212 | 0 |
| K133972 | ASPIRE CRISTALLE | Fujifilm Medical Systems U.S.A, Inc. | 2014-03-25 | 89 | 1 |
| K132210 | FUJIFILM 600 SERIES ENDOSCOPES | Fujifilm Medical Systems U.S.A, Inc. | 2014-01-10 | 178 | 0 |
| K132509 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2013-11-25 | 105 | 0 |
| K123566 | SYNAPSE 3D COLON ANALYSIS | Fujifilm Medical Systems U.S.A, Inc. | 2013-01-22 | 63 | 0 |
| K120679 | SYNAPSE 3D NODULE ANALYSIS | Fujifilm Medical Systems U.S.A, Inc. | 2012-06-01 | 87 | 0 |
| K120361 | SYNAPSE 3D BASE TOOLS | Fujifilm Medical Systems U.S.A, Inc. | 2012-04-06 | 60 | 0 |
| K110729 | ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2011-09-01 | 169 | 1 |
| K103596 | WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR | Fujifilm Medical Systems U.S.A, Inc. | 2011-03-29 | 111 | 0 |
| K103720 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS | Fujifilm Medical Systems U.S.A, Inc. | 2011-03-16 | 85 | 0 |
| K103465 | SYNAPSE 3D CARDIAC TOOLS | Fujifilm Medical Systems U.S.A, Inc. | 2011-01-31 | 68 | 0 |
| K100762 | FLAT PANEL DETECTOR, MODEL FDR D-EVO | Fujifilm Medical Systems U.S.A, Inc. | 2010-07-15 | 120 | 0 |
| K081308 | FUJIFILM FCR VIEW, MODEL CR-VW674 | Fujifilm Medical Systems U.S.A, Inc. | 2008-06-04 | 26 | 0 |
| K080945 | FCR GO PORTABLE DIGITAL X-RAY SYSTEM | Fujifilm Medical Systems U.S.A, Inc. | 2008-04-18 | 15 | 0 |
| K073650 | FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 | Fujifilm Medical Systems U.S.A, Inc. | 2008-02-06 | 42 | 0 |
| K070920 | FUJI IP CASSETTE TYPE PC | Fujifilm Medical Systems U.S.A, Inc. | 2007-05-22 | 50 | 0 |
| K061672 | SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS | Fujifilm Medical Systems U.S.A, Inc. | 2006-06-29 | 15 | 0 |
| K051553 | FUJI SYNAPSE WORKSTATION SOFTWARE | Fujifilm Medical Systems U.S.A, Inc. | 2005-07-07 | 24 | 1 |
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