Company ยท US
Fujifilm Medical System U.S.A., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2017. Name variants (Inc, Corp, punctuation) are merged.
71510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 21 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 12 |
| EAM | Screen, Intensifying, Radiographic | 7 |
| LMC | Camera, Multi Format, Radiological | 7 |
| IXK | System, Imaging, X-Ray, Electrostatic | 4 |
| IXW | Processor, Radiographic-Film, Automatic | 4 |
| KPR | System, X-Ray, Stationary | 3 |
| MUE | Full Field Digital, System, X-Ray, Mammographic | 3 |
| EOQ | Bronchoscope (Flexible Or Rigid) | 2 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 2 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 2 |
| IXA | Cassette, Radiographic Film | 2 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| IZF | System, X-Ray, Tomographic | 1 |
| JAC | System, X-Ray, Film Marking, Radiographic | 1 |
| KGE | Forceps, Biopsy, Electric | 1 |
| LMB | Device, Digital Image Storage, Radiological | 1 |
| LMD | System, Digital Image Communications, Radiological | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 25, 2017 | K163675 | Processor VP-7000, Light Source BL-7000 Fujifilm Medical System U.S.A., Inc. | FET |
| Mar 3, 2016 | K153206 | Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 Fujifilm Medical System U.S.A., Inc. | FDS |
| Feb 18, 2016 | K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) Fujifilm Medical System U.S.A., Inc. | KGE |
| Nov 5, 2015 | K152138 | FDR D-EVO GL Flat Panel Detector System Fujifilm Medical System U.S.A., Inc. | MQB |
| Oct 1, 2015 | K150221 | EPX-4440HD and EPX-4400HD with FICE Fujifilm Medical System U.S.A., Inc. | FET |
| May 14, 2015 | K142629 | EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes Fujifilm Medical System U.S.A., Inc. | FDS |
| Oct 21, 2014 | K142003 | FDR D-EVO II FLAT PANEL DETECTOR SYSTEM Fujifilm Medical System U.S.A., Inc. | MQB |
| Sep 9, 2014 | K133976 | FUJIFILM ENDOSCOPIC CO2 REGULATOR Fujifilm Medical System U.S.A., Inc. | FCX |
| Oct 25, 2013 | K132188 | MAMMOGRAPHY VIEWER SMV658 Fujifilm Medical System U.S.A., Inc. | LLZ |
| Jun 14, 2013 | K130542 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS Fujifilm Medical System U.S.A., Inc. | LLZ |
| Apr 9, 2013 | K130383 | SYNAPSE 3D CARDIAC TOOLS Fujifilm Medical System U.S.A., Inc. | LLZ |
| Dec 13, 2012 | K122535 | FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H Fujifilm Medical System U.S.A., Inc. | EOQ |
| Nov 20, 2012 | K122454 | FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION Fujifilm Medical System U.S.A., Inc. | KPR |
| Nov 20, 2012 | K121499 | FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM Fujifilm Medical System U.S.A., Inc. | IZF |
| Sep 21, 2012 | K121674 | ASPIRE HD PLUS, ASPIRE HD-S Fujifilm Medical System U.S.A., Inc. | MUE |
| Aug 28, 2012 | K120629 | FDR GO FLEX Fujifilm Medical System U.S.A., Inc. | MQB |
| Jul 5, 2012 | K120636 | SYNAPSE 3D CARDIAC TOOLS Fujifilm Medical System U.S.A., Inc. | LLZ |
| Jun 14, 2012 | K120648 | SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS Fujifilm Medical System U.S.A., Inc. | LLZ |
| Jun 4, 2012 | K121035 | FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US Fujifilm Medical System U.S.A., Inc. | EOQ |
| May 8, 2012 | K120637 | SYNAPSE 3D BRAIN PERFUSION Fujifilm Medical System U.S.A., Inc. | LLZ |
| Dec 22, 2011 | K113244 | SYNAPSE MPR FUSION Fujifilm Medical System U.S.A., Inc. | LLZ |
| Dec 8, 2011 | K111646 | ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR Fujifilm Medical System U.S.A., Inc. | MUE |
| Oct 17, 2011 | K112439 | SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 Fujifilm Medical System U.S.A., Inc. | LLZ |
| Sep 30, 2011 | K111865 | WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE Fujifilm Medical System U.S.A., Inc. | MQB |
| Aug 30, 2011 | K111548 | WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE Fujifilm Medical System U.S.A., Inc. | MQB |
| Apr 7, 2011 | K110186 | SYNAPSE 3D LIVER ANALYSIS Fujifilm Medical System U.S.A., Inc. | LLZ |
| Mar 4, 2011 | K103687 | SYNAPSE 3D CEREBRAL ANALYSIS Fujifilm Medical System U.S.A., Inc. | LLZ |
| Feb 8, 2011 | K110202 | FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB Fujifilm Medical System U.S.A., Inc. | ITX |
| Oct 29, 2010 | K101686 | FDR IMAGE STITCHING OPTION Fujifilm Medical System U.S.A., Inc. | KPR |
| Jul 26, 2010 | K101662 | SYNAPSE 3D BASIC TOOLS Fujifilm Medical System U.S.A., Inc. | LLZ |
| Apr 14, 2010 | K100881 | SYNAPSE OBLIQUUS MIP/MPR/FUSION Fujifilm Medical System U.S.A., Inc. | LLZ |
| Jan 21, 2010 | K093427 | FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR Fujifilm Medical System U.S.A., Inc. | MQB |
| Aug 25, 2004 | K042023 | FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER Fujifilm Medical System U.S.A., Inc. | MQB |
| Aug 6, 2004 | K041990 | FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP Fujifilm Medical System U.S.A., Inc. | LLZ |
| Jan 9, 2004 | K033377 | FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L Fujifilm Medical System U.S.A., Inc. | LMC |
| Nov 26, 2003 | K033561 | FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER Fujifilm Medical System U.S.A., Inc. | MQB |
| Dec 20, 2001 | K013218 | FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II Fujifilm Medical System U.S.A., Inc. | MQB |
| Feb 10, 2000 | K993861 | FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER Fujifilm Medical System U.S.A., Inc. | MQB |
| Jun 25, 1999 | K991257 | FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION Fujifilm Medical System U.S.A., Inc. | LLZ |
| Sep 12, 1997 | K972256 | FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS) Fujifilm Medical System U.S.A., Inc. | LLZ |
| Mar 31, 1997 | K970349 | FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667 Fujifilm Medical System U.S.A., Inc. | LLZ |
| Mar 21, 1997 | K970293 | FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666 Fujifilm Medical System U.S.A., Inc. | LMD |
| Oct 28, 1996 | K962967 | FUJI MEDICAL DRY IMAGER FM-DP 2636 Fujifilm Medical System U.S.A., Inc. | LMC |
| Mar 7, 1996 | K960326 | FCR DMS OPTICAL DISK IMAGE FILING UNIT OD-F614, ODF614L & MULTIMODALITY SYSTEM Fujifilm Medical System U.S.A., Inc. | LMB |
| Oct 27, 1995 | K951373 | FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ Fujifilm Medical System U.S.A., Inc. | IXW |
| Sep 20, 1995 | K952862 | FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR Fujifilm Medical System U.S.A., Inc. | LLZ |
| May 24, 1995 | K950721 | FUJI MEDICAL LASER IMAGERMULTI-FORMATTERS MF-300 AND MF-300L Fujifilm Medical System U.S.A., Inc. | LMC |
| May 11, 1995 | K944046 | FUJI COMPUTED RADIOGRAPHY SYSTEMS Fujifilm Medical System U.S.A., Inc. | IXW |
| Apr 25, 1995 | K950610 | FIKO FO;, TJER,A; O,AGER FTO-1000 Fujifilm Medical System U.S.A., Inc. | LMC |
| Mar 9, 1995 | K945475 | FUJI MEDICAL LASER IMAGER FL-IM D Fujifilm Medical System U.S.A., Inc. | LMC |
Newest 50 of 71.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2014 | Fujifilm Medical System USA, Inc. MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation.
x-ray generator Terminated |
MUE | None listed |
| Mar 15, 2006 | Fujifilm Medical System USA, Inc. Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS Terminated |
LLZ | K051553 |
| Oct 28, 2004 | Fujifilm Medical System USA, Inc. Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1.
Model: GP344 Terminated |
MQB | K993861 |
| Jul 20, 2004 | Fujifilm Medical System USA, Inc. Fuji Flash IIP and CR-IR346CL Consoles Terminated |
MQB | K013218 |
| Jun 12, 2003 | Fujifilm Medical System USA, Inc. Synapse Version 2.2.1 and 2.3.1 software Terminated |
LLZ | K991257 |