Full Field Digital, System, X-Ray, Mammographic
Regulation 892.1715
4510(k)s in 12 months (56 all time)
5recalls in 12 months (41 all time)
22recalls that name a 510(k)
Top companies in MUE
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 7 | 12 |
| GE Healthcare | 9 | 9 |
| Fujifilm Medical Systems U.S.A, Inc. | 3 | 8 |
| Hologic, Inc. | 2 | 5 |
| Planmed OY | 4 | 0 |
| DRTECH Corporation | 3 | 0 |
| Fujifilm Medical System U.S.A., Inc. | 2 | 1 |
| GE Medical Systems SCS | 2 | 1 |
| Philips Digital Mammography Sweden AB | 3 | 0 |
| Fischer Imaging Corporation | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2026 | Hologic, Inc SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, Open, Classified |
MUE | None listed |
| Dec 9, 2025 | GE Medical Systems, LLC Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography Open, Classified |
MUE | K162268 K173576 +1 |
| Dec 3, 2025 | Siemens Medical Solutions USA, Inc MAMMOMAT Fusion; Open, Classified |
MUE | K151645 |
| Dec 3, 2025 | Siemens Medical Solutions USA, Inc MAMMOMAT Inspiration; Open, Classified |
MUE | K123520 |
| Dec 3, 2025 | Siemens Medical Solutions USA, Inc MAMMOMAT Revelation; Open, Classified |
MUE | K193166 |
| Feb 8, 2024 | GE Medical Systems, SCS Senographe Pristina Open, Classified |
MUE | K162268 K173576 +3 |
| Jun 16, 2020 | Siemens Medical Solutions USA, Inc MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical prof Terminated |
MUE | K173408 |
| Feb 18, 2020 | Hologic, Inc. Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636, Terminated |
MUE | None listed |
| Jul 23, 2019 | Siemens Medical Solutions USA, Inc Mammomat Revelation with software version VC10 and Biopsy Option
Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures Terminated |
MUE | K173408 |
| May 16, 2019 | GE Healthcare, LLC 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. Terminated |
MUE | K173576 |
| May 16, 2019 | GE Healthcare, LLC 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 Terminated |
MUE | K162268 |
| Dec 6, 2018 | Hologic, Inc. I-View Contrast Enhanced Digital Mammography, ASY-08109 Terminated |
MUE | K123873 |
| 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 |
| Jan 11, 2017 | Siemens Medical Solutions USA, Inc 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 un Terminated |
MUE | K122286 |
| 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 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 |
| Dec 6, 2014 | Siemens Medical Solutions USA, Inc Mammomat Inspiration system:
Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted Terminated |
MUE | K122286 |
| Oct 17, 2014 | Siemens Medical Solutions USA, Inc Siemens Mammomat Inspiration mammography systems.
The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical Terminated |
MUE | K122286 |
| Jun 13, 2014 | Beekley Corporation Beekley Spots Light Image O-Spots for Mammography
Catalog Number: 252
Product Usage: To identify raised moles in Mammography Terminated |
MUE | None listed |
| Jun 3, 2014 | Hologic, Inc. 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 u Terminated |
MUE | None listed |
| 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 |
| May 20, 2014 | Siemens Medical Solutions USA, Inc MAMMOMAT Inspiration.
Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Terminated |
MUE | K122286 |
| Sep 30, 2013 | Hologic, Inc. Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x
The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screen Terminated |
MUE | None listed |
| Jul 11, 2013 | Siemens Medical Solutions USA, Inc Siemens Mammomat Inspiration - full-field digital mammography
Product Usage: Mammography Terminated |
MUE | K122286 |
| Jun 26, 2013 | GE Healthcare, LLC 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 2000 Terminated |
MUE | None listed |
| Feb 20, 2012 | GE Healthcare, LLC 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 breas Terminated |
MUE | None listed |
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc MAMMOMAT Inspiration
Full field digital mammographic x-ray system Terminated |
MUE | None listed |
| Oct 26, 2011 | GE Healthcare, LLC GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM.
The Senographe DS system generates digital mammographic images, which can be used for screening and diagnosis of breast cancer. The S Terminated |
MUE | None listed |
| Oct 26, 2011 | GE Healthcare, LLC 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/scree Terminated |
MUE | None listed |
| Mar 18, 2011 | GE Healthcare, LLC 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 Terminated |
MUE | None listed |
| Mar 17, 2011 | GE Healthcare, LLC GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM
MAMMOGRAPHIC FILM / SCREEN SYSTEM Terminated |
MUE | None listed |
| Mar 17, 2011 | GE Healthcare, LLC 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 ge Terminated |
MUE | None listed |
| May 7, 2009 | Siemens Medical Solutions USA, Inc Siemens Mammomat Novation DR, full field digital mammography system. Model Number 06646900.
The device is used for full field digital mammography system. Terminated |
MUE | None listed |
| May 28, 2008 | Lorad, A Hologic, Inc. 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 Terminated |
MUE | None listed |
| Apr 11, 2006 | Fischer Imaging Corporation SenoScan Full Field Digital Mammography System--Product Number 94001G-3, 105200G Terminated |
MUE | None listed |
| Jul 20, 2004 | Fischer Imaging Corporation Fischer SenoScan True View Digital Mammography System. Terminated |
MUE | None listed |
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