Fujifilm Medical Systems U S A Inc

FDA Filings

This page includes the latest FDA filings for Fujifilm Medical Systems U S A Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Fujifilm Medical Systems U S A Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3004972322
FEI Number3004972322
NameFUJIFILM Medical Systems U.S.A., Inc.
Owner & OperatorFUJIFILM CORPORATION
Contact Address26-30 NISHIAZABU, 2-CHOME
MINATO-KU JP-13 Tokyo 106-8620 JP
Official Correspondent
  • Randy Vader
  • 81-360-3566821-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3020 CARRINGTON MILL BLVD STE 500
Morrisville, NC 27560 US
Establishment TypeManufacture Medical Device



Registration Number3005625991
FEI Number3005625991
NameFUJIFILM Medical Systems U.S.A., Inc.
Owner & OperatorFUJIFILM CORPORATION
Contact Address26-30 NISHIAZABU, 2-CHOME
MINATO-KU JP-13 Tokyo 106-8620 JP
Official Correspondent
  • Randy Vader
  • 81-360-3566821-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1100 King Georges Post Rd
Edison, NJ 08837 US



Registration Number1000513161
FEI Number1000513161
NameFujifilm Medical Systems U.S.A., Inc
Owner & OperatorFUJIFILM CORPORATION
Contact Address26-30 NISHIAZABU, 2-CHOME
MINATO-KU JP-13 Tokyo 106-8620 JP
Official Correspondent
  • Randy Vader
  • 81-360-3566821-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address81 Hartwell Avenue, Suite 300
Lexington, MA 02421 US



Registration Number2431293
FEI Number2431293
NameFUJIFILM Medical Systems U.S.A., Inc.
Owner & OperatorFUJIFILM CORPORATION
Contact Address26-30 NISHIAZABU, 2-CHOME
MINATO-KU JP-13 Tokyo 106-8620 JP
Official Correspondent
  • Randy Vader
  • 81-360-3566821-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address10 HIGH POINT DR.
Wayne, NJ 07470 US



Registration Number3003991612
FEI Number3003991612
NameRandy Vader
Owner & OperatorFUJIFILM Medical Systems U.S.A., Inc.
Contact Address81 Hartwell Ave, Suite 300
Lexington MA 02421 US
Official Correspondent
  • Randy Vader
  • x-360-3566821-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address81 Hartwell Avenue, Suite 300
Lexington, MA 02421 US
Establishment TypeManufacture Medical Device for Another Party (Contract Manufacturer)



Registration Number3012206788
FEI Number3012206788
NameFUJIFILM Medical Systems U.S.A., Inc.
Owner & OperatorFUJIFILM CORPORATION
Contact Address26-30 NISHIAZABU, 2-CHOME
MINATO-KU JP-13 Tokyo 106-8620 JP
Official Correspondent
  • Randy Vader
  • 81-360-3566821-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address6200 Phyllis Dr
Cypress, CA 90630 US



FDA Filings

Device
Company
DeviceDate
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option2020-09-30
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Aspire Cristalle Digital Breast Tomosynthesis Option2019-10-25
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse Enterprise Viewer 2019-05-31
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse Mobility 2019-05-29
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse MPR Fusion 2019-05-29
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse Cardiology PACS 2019-05-29
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse Radiology PACS 2019-05-29
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION]
Synapse Enterprise Viewer Version 1.02019-05-07
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION]
Synapse PACS2019-03-28
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
ASPIRE Cristalle Breast Tomosynthesis System2019-02-08
FUJIFILM Medical Systems U.S.A., Inc.
FUJIFILM Bronchoscope Model EB-530P2018-01-19
FUJIFILM Medical Systems U.S.A., Inc.
FUJIFILM Ultrasonic Processor SP-900 And FUJIFILM Ultrasonic Probe PB2020-M2018-01-11
Fujifilm Medical Systems U.S.A., Inc.
ASPIRE Cristalle2017-10-27
FUJIFILM Medical Systems U.S.A., Inc.
ASPIRE Bellus II2017-09-29
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Fujifilm Duodenoscope Model ED-530XT2017-07-21
FUJIFILM Medical Systems U.S.A., Inc.
Dynamic Visualization II Image Processing Option For The FDX Console (DR-ID300CL Of The DR-ID600)2017-06-30
FUJIFILM Medical Systems U.S.A., Inc.
FUJIFILM Hood Models DH-28GR, DH-29CR And DH-30CR2017-06-15
Randy Vader [FUJIFILM Medical Systems U.S.A., Inc.]
WB7025DC Cleaning Brush2017-05-26
Randy Vader [FUJIFILM Medical Systems U.S.A., Inc.]
WB11003DV Cleaning Brush2017-05-26
FUJIFILM Medical Systems U.S.A., Inc.
Fujifilm Diathermic Slitter (FlushKnife)2017-05-09
FUJIFILM Medical Systems U.S.A., Inc.
FDR AQRO (DR-XD 1000)2017-04-24
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse 3D Perfusion Analysis2017-04-06
FUJIFILM Medical Systems U.S.A., Inc.
FDX Console (DR-ID300CL) Software2017-03-16
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION2017-01-10
FUJIFILM Medical Systems U.S.A., Inc.
Fujifilm Endoscope Models EC-600HL And EC-600LS2016-10-18
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)2016-06-29
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
FDR D-EVO Flat Panel Detector System2016-04-08
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION]
Synapse CardioVascular2016-04-07
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION]
Synapse PACS2016-03-28
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION]
Synapse 52016-03-28
FUJIFILM Medical Systems U.S.A., Inc.
Fujifilm Video Colonoscope Model EC-600WL V22016-02-23
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse PACS2016-02-03
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Balloon Controller PB-302015-12-15
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Fujifilm Double Balloon Endoscopes Models EN-530T And EN-580T2015-08-20
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
Synapse Cardiovascular2015-08-12
FUJIFILM Medical Systems U.S.A., Inc.
FUJIFILM Endoscope Models EC-600HL And EC-600LS2015-07-06
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
FDR D-EVO FLAT PANEL DETECTOR SYSTEM2014-10-03
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
EPX-4440HD DIGITAL VIDEO PROCESSOR2014-08-22
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
FUJIFILM 600 SERIES ENDOSCOPES2014-01-10
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
SYNAPSE 3D COLON ANALYSIS2013-01-22
FUJIFILM Medical Systems U.S.A., Inc. [FUJIFILM CORPORATION]
Fujifilm Synapse Workstation Software2012-08-31
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
SYNAPSE 3D NODULE ANALYSIS2012-06-01
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR2011-03-29
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS2011-03-16
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
SYNAPSE 3D CARDIAC TOOLS2011-01-31
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
FLAT PANEL DETECTOR, MODEL FDR D-EVO2010-07-15
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
FUJIFILM FCR VIEW, MODEL CR-VW6742008-06-04
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
FCR GO PORTABLE DIGITAL X-RAY SYSTEM2008-04-18
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
FUJI IP CASSETTE TYPE PC2007-05-22

Similar & Related FDA Registered Companies

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091185951Tokyo ,Japan -> Los Angeles, CaliforniaFUJI MEDICAL FILM HS CODE:3701.10390 PCS
2020081523013Pusan,South Korea -> New York/Newark Area, Newark, New JerseyFUJI MEDICAL EQUIPMENT (MAMMOGRAPHY OPTION) HS CODE:9022.9019 PKG
2020062651002Tokyo ,Japan -> Los Angeles, CaliforniaFUJI MEDICAL FILM HS CODE:3701.10, 3701.3081 PCS
202005237812Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS22 PKG
2020051611407Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS1 PKG
2020051123078Pusan,South Korea -> New York/Newark Area, Newark, New JerseyRADIATION GENERATOR UNITS4 CAS
2020051123077Pusan,South Korea -> New York/Newark Area, Newark, New JerseyRADIATION GENERATOR UNITS4 CAS
2020050421854Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENTS3 PKG

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