BEUDAMED
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    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code MUE·May 13, 2014

    GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·January 14, 2013

    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUE·February 28, 2013

    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.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·June 9, 2016

    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 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.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·August 4, 2017

    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 that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·August 4, 2017

    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 images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·July 14, 2017

    Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUE·July 23, 2019

    Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number: SEL-00002; Hologic, Danbury CT 06810

    FDA Recall
    Terminated ·Lorad, A Hologic, Inc.·Product code MUE·February 28, 2008

    GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·September 22, 2011

    GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected usage of this product is for the same clinical applications as traditional mammographic film/screen systems. It generates mammographic images which can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·July 20, 2010

    MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator

    FDA Recall
    Terminated ·Fujifilm Medical System USA, Inc.·Product code MUE·June 29, 2012

    Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUE·September 18, 2014

    GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·October 17, 2011

    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 Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·August 4, 2017

    GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·May 16, 2019

    Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code MUE·January 11, 2017

    GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional film-based mammographic systems.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·May 16, 2019

    Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography

    FDA Recall
    Terminated ·Beekley Corporation·Product code MUE·June 19, 2013

    GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe Essential system is intended to be used in the same clinical applications as traditional mammographic film/screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MUE·January 19, 2011