Company ยท US
Fujifilm Medical Systems U.S.A, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2018. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
37recalls (0 in 12 months)
36recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 21 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 11 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 11 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 6 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 5 |
| IZL | System, X-Ray, Mobile | 4 |
| DQK | Computer, Diagnostic, Programmable | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 2 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 |
| KGE | Forceps, Biopsy, Electric | 2 |
| KPR | System, X-Ray, Stationary | 2 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 1 |
| FDA | Enteroscope And Accessories | 1 |
| IXW | Processor, Radiographic-Film, Automatic | 1 |
| IYE | Accelerator, Linear, Medical | 1 |
| JIS | Calibrator, Primary | 1 |
| NSF | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | 1 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 1 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2018 | K171291 | FUJIFILM Bronchoscope Model EB-530P Fujifilm Medical Systems U.S.A, Inc. | EOQ |
| Jan 11, 2018 | K171207 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M Fujifilm Medical Systems U.S.A, Inc. | ODG |
| Oct 27, 2017 | K173132 | ASPIRE Cristalle Fujifilm Medical Systems U.S.A, Inc. | MUE |
| Sep 29, 2017 | K171463 | ASPIRE Bellus II Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Jul 21, 2017 | K152257 | Fujifilm Duodenoscope Model ED-530XT Fujifilm Medical Systems U.S.A, Inc. | FDT |
| Jun 30, 2017 | K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Jun 15, 2017 | K162749 | FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR Fujifilm Medical Systems U.S.A, Inc. | FDS |
| May 9, 2017 | K171096 | Fujifilm Diathermic Slitter (FlushKnife) Fujifilm Medical Systems U.S.A, Inc. | KGE |
| Apr 24, 2017 | K170858 | FDR AQRO (DR-XD 1000) Fujifilm Medical Systems U.S.A, Inc. | IZL |
| Apr 6, 2017 | K162287 | Synapse 3D Perfusion Analysis Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Mar 16, 2017 | K170451 | FDX Console (DR-ID300CL) Software Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Oct 18, 2016 | K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS Fujifilm Medical Systems U.S.A, Inc. | FDF |
| Jun 29, 2016 | K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) Fujifilm Medical Systems U.S.A, Inc. | KGE |
| Apr 8, 2016 | K153464 | FDR D-EVO flat Panel Detector System Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Feb 23, 2016 | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 Fujifilm Medical Systems U.S.A, Inc. | FDF |
| Feb 3, 2016 | K160108 | Synapse PACS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Dec 15, 2015 | K153483 | Balloon controller PB-30 Fujifilm Medical Systems U.S.A, Inc. | FDF |
| Aug 20, 2015 | K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T Fujifilm Medical Systems U.S.A, Inc. | FDA |
| Aug 12, 2015 | K151859 | Synapse Cardiovascular Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Jul 6, 2015 | K143732 | FUJIFILM Endoscope Models EC-600HL and EC-600LS Fujifilm Medical Systems U.S.A, Inc. | FDF |
| Oct 3, 2014 | K141765 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Aug 22, 2014 | K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR Fujifilm Medical Systems U.S.A, Inc. | PEA |
| Mar 25, 2014 | K133972 | ASPIRE CRISTALLE Fujifilm Medical Systems U.S.A, Inc. | MUE |
| Jan 10, 2014 | K132210 | FUJIFILM 600 SERIES ENDOSCOPES Fujifilm Medical Systems U.S.A, Inc. | FDF |
| Nov 25, 2013 | K132509 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Jan 22, 2013 | K123566 | SYNAPSE 3D COLON ANALYSIS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Jun 1, 2012 | K120679 | SYNAPSE 3D NODULE ANALYSIS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Apr 6, 2012 | K120361 | SYNAPSE 3D BASE TOOLS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Sep 1, 2011 | K110729 | ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM Fujifilm Medical Systems U.S.A, Inc. | MUE |
| Mar 29, 2011 | K103596 | WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Mar 16, 2011 | K103720 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Jan 31, 2011 | K103465 | SYNAPSE 3D CARDIAC TOOLS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Jul 15, 2010 | K100762 | FLAT PANEL DETECTOR, MODEL FDR D-EVO Fujifilm Medical Systems U.S.A, Inc. | MQB |
| Jun 4, 2008 | K081308 | FUJIFILM FCR VIEW, MODEL CR-VW674 Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Apr 18, 2008 | K080945 | FCR GO PORTABLE DIGITAL X-RAY SYSTEM Fujifilm Medical Systems U.S.A, Inc. | IZL |
| Feb 6, 2008 | K073650 | FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 Fujifilm Medical Systems U.S.A, Inc. | KPR |
| May 22, 2007 | K070920 | FUJI IP CASSETTE TYPE PC Fujifilm Medical Systems U.S.A, Inc. | IYE |
| Jun 29, 2006 | K061672 | SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS Fujifilm Medical Systems U.S.A, Inc. | LLZ |
| Jul 7, 2005 | K051553 | FUJI SYNAPSE WORKSTATION SOFTWARE Fujifilm Medical Systems U.S.A, Inc. | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2021 | Fujifilm Medical Systems U.S.A., Inc. Synapse Cardiovascular (Synapse CV).
Software Versions: 6.0 to 6.2.1
The Synapse Cardiovascular image is a management and reporting system Terminated |
LLZ | K151859 |
| Mar 2, 2021 | Fujifilm Medical Systems U.S.A., Inc. Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Open, Classified |
LLZ | K160108 |
| Feb 18, 2021 | Fujifilm Medical Systems U.S.A., Inc. TASWako Chip Cassette is part of the Wako TASWako i30 kit Terminated |
NSF | K100464 |
| Dec 22, 2020 | Fujifilm Medical Systems U.S.A., Inc. Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein Terminated |
JIS | K001005 |
| Dec 11, 2020 | Fujifilm Medical Systems U.S.A., Inc. FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is netwo Terminated |
LLZ | K190232 |
| Sep 11, 2020 | Fujifilm Medical Systems U.S.A., Inc. Synapse PACS Software Versions 5.1 and higher Open, Classified |
LLZ | K160108 |
| Sep 11, 2020 | Fujifilm Medical Systems U.S.A., Inc. Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM S Terminated |
LLZ | K190232 |
| May 22, 2020 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) Open, Classified |
LLZ | K160108 |
| Jul 19, 2019 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm FDR Go Plus mobile X-ray system Terminated |
IZL | K080701 |
| Jan 15, 2019 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm FDR Go PLUS, Mobile X-Ray System
Product Usage:
This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatient Terminated |
IZL | K080701 |
| Jan 17, 2018 | Fujifilm Medical Systems U.S.A., Inc. ASPIRE Cristalle (FDR MS-3500) Mammography machine
The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography image Terminated |
MUE | K133972 |
| Jan 17, 2018 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000),
also known as Aspire HD Plus S). Mammography machine
The Fujifilm Digital Mammography Systems, Aspire HD Terminated |
MUE | K121674 |
| Aug 4, 2017 | Fujifilm Medical Systems U.S.A., Inc. Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS)
The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Terminated |
MUE | None listed |
| Aug 4, 2017 | Fujifilm Medical Systems U.S.A., Inc. ASPIRE Cristalle (for FDR-3000AWS)
The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammo Terminated |
MUE | K133972 |
| Aug 4, 2017 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD Plus, Aspire HD-s (for FDR-2000AWS)
The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images tha Terminated |
MUE | K121674 |
| Aug 4, 2017 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD (for FDR-1000AWS)
The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems Terminated |
MUE | K110729 |
| Jul 21, 2017 | Fujifilm Medical Systems U.S.A., Inc. FUJINON ED-530XT.
This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, st Terminated |
FDT | K152257 |
| Jun 15, 2017 | Fujifilm Medical Systems U.S.A., Inc. FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name)
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of Terminated |
KPR | K152294 |
| Feb 17, 2017 | Fujifilm Medical Systems U.S.A., Inc. Ultrasonic Endoscope
Model Number EG-530UT
A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs Terminated |
FDS | K063847 |
| Sep 15, 2016 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image Terminated |
LLZ | K112439 |
| Jun 9, 2016 | Fujifilm Medical Systems U.S.A., Inc. FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY)
The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammogr Terminated |
MUE | K110729 K113284 |
| May 10, 2016 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS software version 4.4.000,
Fujifilm Synapse PACS software version 4.4.001,
Fujifilm Synapse PACS software version 4.4.004,
Fujifilm Synapse PACS software version 4.4.010 and
Fujif Terminated |
LLZ | K112439 |
| Apr 1, 2016 | Fujifilm Medical Systems U.S.A., Inc. Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU Terminated |
IXW | K944046 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-450XL5
Operation Manual: Cleaning, Disinfection and Storage Terminated |
FDT | K042076 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-450XT5
Operation Manual: Cleaning, Disinfection and Storage Terminated |
FDT | K042076 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-250XT5
Operations Manual: Cleaning Disinfection and Storage Terminated |
FDT | K944759 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope
ED-250XL5 Operations Manual: Cleaning, Disinfection Terminated |
FDT | K944759 |
| Dec 23, 2015 | Fujifilm Medical Systems U.S.A., Inc. Endoscope; ED-530XT Operation Manual
'Operation and Preparation' and 'Cleaning, Disinfection and Storage' Terminated |
FDT | K042076 |
| Sep 22, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure).
For use in endoscopic procedures. Used to observe, record and capture images. Terminated |
FET | K944759 |
| Sep 22, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures. Terminated |
FET | K944759 |
| Sep 17, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals. Terminated |
FDT | K042076 K944620 |
| Aug 31, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. Terminated |
FDT | K944759 |
| May 14, 2015 | Fujifilm Medical Systems U.S.A., Inc. FujiMedical Synapse Cardiovascular I ProSolv CardioVascular.
A picture Archiving and Communication System
Software versions:
Synapse Cardiovascular v4.0.8
Synapse Cardiovascular v4.0.8 SR1 Terminated |
DQK | K023112 |
| May 14, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse Cardiovascular I ProSolv CardioVascular
Synapse Cardiovascular v4.0.8
Synapse Cardiovascular v4.0.8 SR1
Intended Use:
Picture Archiving and Communication System
Computer, Diagnosti Terminated |
DQK | K023112 |
| May 6, 2015 | Fujifilm Medical Systems U.S.A., Inc. Aspire HD, Full Field Digital, System, x-Ray, Mammographic;
Model: FOR MS-1000.
A mammography system used for screening and diagnosis of breast cancer. Terminated |
MUE | K110729 |
| Mar 9, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Endoscope
Models
ED-250XL5
ED-250XT5
ED-450XT5
ED-450XL5
Product Usage:
This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, d Terminated |
FDT | K152257 |
| Mar 9, 2015 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Endoscope
Model ED-530XT
Product Usage:
This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of Terminated |
FDT | K152257 |