Manufacturers

Fujifilm Medical Systems U.S.A., Inc.

14 devices in the database

Device Recall Fujifilm Aspire HD, Full Field Digital, System
  • Model / Serial
    Serial Number: 26320119
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in HI.
  • Product Description
    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; || Model: FOR MS-1000. || A mammography system used for screening and diagnosis of breast cancer.
Device Recall Fujifilm Medical Systems
  • Model / Serial
    Software Versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.
  • Product Description
    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, Diagnostic, Programmable
Device Recall FujiMedical
  • Model / Serial
    Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
  • Product Description
    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
Device Recall FUJIFILM Synapse Workstation Versions 4.4.000, 4.4.001, 4.4.004, 4.4.010, and 4.4.020
  • Model / Serial
    Software version: 4.4.000, 4.4.001, 4.4.004, 4.4.010, 4.4.020
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: CA, FL, KS, NE, NY, and PA.
  • Product Description
    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 || Fujifilm Synapse PACS software version 4.4.020 || FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an || off-the-shelf PC networked with Fuji Synapse PACS.
Device Recall FUJIFILM Digital Mammography System Aspire HD (FDR MS1000) with Biopsy Positioner ...
  • Model / Serial
    26330437 and 17230408
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to: NC and HI.
  • Product Description
    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 mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
9 more

2 manufacturers with a similar name

Learn more about the data here

Fujifilm Medical Systems U.S.A., Inc.
  • Manufacturer Address
    Fujifilm Medical Systems U.S.A., Inc., 10 Highpoint Dr, Wayne NJ 07470-7431
  • Manufacturer Parent Company (2017)
    FUJIFILM Holdings Corp.
  • Source
    USFDA
FUJIFILM Medical Systems U.S.A., Inc.