FDA 510(k) Applications Submitted by FUJIFILM Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K220053 01/06/2022 Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI FUJIFILM Corporation
K210162 01/21/2021 Endoscope Model EI-740D/S FUJIFILM Corporation
K190232 02/06/2019 Synapse PACS FUJIFILM Corporation
K180341 02/07/2018 FUJIFILM 600 Series Endoscope EG-600WR v2 FUJIFILM Corporation
K180405 02/14/2018 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Corporation
K190649 03/13/2019 FUJIFILM Endoscope Model EC-760S-V/L FUJIFILM Corporation
K200668 03/13/2020 DR-ID 1200SDK System FUJIFILM Corporation
K180711 03/19/2018 FUJIFILM Endoscopic CO2 Regulator GW-100 FUJIFILM Corporation
K200850 03/31/2020 Fujifilm Ultrasonic Processor FUJIFILM Corporation
K221238 04/29/2022 FUJIFILM Ultrasonic Endoscope EG-740UT FUJIFILM Corporation
K191495 06/05/2019 Biopsy Positioner FUJIFILM Corporation
K221677 06/09/2022 Synapse 3D Base Tools v6.6 FUJIFILM Corporation
K191544 06/11/2019 Synapse 3D Blood Flow Analysis Fujifilm Corporation
K191747 07/01/2019 FUJIFILM Duodenoscope Model ED-580XT FUJIFILM Corporation
K181745 07/02/2018 FUJIFILM Duodenoscope Model FUJIFILM Corporation
K181763 07/03/2018 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation
K181773 07/03/2018 Synapse 3D Optional Tools FUJIFILM Corporation
K221952 07/05/2022 Endoscope Model EG-580UT and Endoscope Model EG-580UR FUJIFILM Corporation
K212296 07/22/2021 Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 FUJIFILM Corporation
K182051 07/31/2018 FUJIFILM Duodenoscope Model FUJIFILM Corporation
K202130 07/31/2020 FUJIFILM Video Laparoscope Fujifilm Corporation
K182253 08/20/2018 FUJIFILM Video Bronchoscopes FUJIFILM Corporation
K192286 08/22/2019 FUJIFILM EP-6000 Video Processor FUJIFILM Corporation
K192440 09/06/2019 FDR SE Lite Fujifilm Corporation
K212873 09/09/2021 Aspire Cristalle FUJIFILM Corporation
K212956 09/16/2021 FDR Cross (DR-XD 3000) FUJIFILM Corporation
K172916 09/25/2017 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 Fujifilm Corporation
K192664 09/25/2019 FUJIFILM Endoscope Model EC-760Z-V/L FUJIFILM Corporation
K213195 09/29/2021 Balloon BS-3 FUJIFILM Corporation
K203028 10/02/2020 FUJIFILM Distal End Cap Fujifilm Corporation
K182825 10/04/2018 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation
K182836 10/09/2018 FUJIFILM Endoscope Model EG-740N FUJIFILM Corporation
K203103 10/14/2020 Synapse 3D, Synapse 3D Base Tools v6.1 Fujifilm Corporation
K192918 10/15/2019 Video Laparoscope, Video Processor, Light Source FUJIFILM Corporation
K192932 10/17/2019 FDR D-EVO III flat panel detector system FUJIFILM Corporation
K193123 11/12/2019 FUJIFILM Distal Cap Models 33-40 FUJIFILM Corporation
K183248 11/21/2018 Synapse Enterprise Viewer Version 1.0 FUJIFILM Corporation
K183433 12/11/2018 FUJIFILM Ultrasonic Endoscope Fujifilm Corporation
K183572 12/21/2018 FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L FUJIFILM Corporation
K223827 12/21/2022 FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 FUJIFILM Corporation
K183607 12/26/2018 FUJIFILM Bronchoscope FUJIFILM Corporation
K183686 12/28/2018 FUJIFILM Endoscope Model EG-530N Fujifilm Corporation
K183683 12/28/2018 FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 FUJIFILM Corporation
K214089 12/28/2021 FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 Fujifilm Corporation
K183032 11/01/2018 FUJIFILM Double Balloon Endoscope EI580BT FUJIFILM Corporation


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