Full Field Digital, System, X-Ray, Mammographic
FDA product code MUE · Class II (moderate risk) · 21 CFR 892.1715 · Radiology
56510(k) clearances
6PMA approvals
39recalls
Manufacturers
- GE Healthcare, LLC 9
- Siemens Medical Solutions USA, Inc. 7
- Planmed OY 4
- Fujifilm Medical Systems U.S.A, Inc. 3
- DRTECH Corporation 3
- Philips Digital Mammography Sweden AB 3
- Rayence Co., Ltd. 2
- Vieworks Co., Ltd. 2
- GE Medical Systems SCS 2
- Hologic, Inc. 2
- Fujifilm Medical System U.S.A., Inc. 2
- General Electric Co. 2
- Carestream Health, Inc. 1
- Genoray Co., Ltd. 1
- Agfa Healthcare N.V. 1
- Icrco, Inc. 1
- Giotto USA, LLC 1
- Planmeca USA, Inc. 1
- Adani 1
- Philips Medical Systems 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254090 | I-View®MUE · Traditional | Hologic, Inc. | 09/02/2026SE |
| K253678 | MAMMOMAT B.brilliant (11372950)MUE · Traditional | Siemens Medical Solutions USA, Inc. | 06/18/2026SE |
| K254092 | Bellalun 2D (VDMS-1000S)MUE · Traditional | Vieworks Co., Ltd. | 05/28/2026SE |
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightMUE · Traditional | GE Medical Systems SCS | 03/24/2026SE |
| K243420 | HestiaMUE · Traditional | Genoray Co., Ltd. | 07/17/2025SE |
| K243849 | 2430TCA with Xmaru WMUE · Special | Rayence Co., Ltd. | 03/12/2025SE |
| K241113 | Vivix-MMUE · Traditional | Vieworks Co., Ltd. | 01/16/2025SE |
| K233539 | MAMMOMAT B.brilliantMUE · Traditional | Siemens Medical Solutions USA, Inc. | 03/27/2024SE |
| K220073 | RMF-2000MUE · Traditional | DRTECH Corporation | 01/26/2023SE |
| K211720 | Planmed Clarity 2D, Planmed Clarify SMUE · Traditional | Planmed OY | 07/18/2022SE |
| K212873 | Aspire CristalleMUE · Traditional | Fujifilm Corporation | 05/27/2022SE |
| K210151 | Digimamo DMUE · Traditional | Vmi Tecnologias Ltda | 03/01/2022SE |
| K202822 | HelianthusMUE · Traditional | Metaltronica Spa | 12/15/2021SE |
| K211725 | Senographe PristinaMUE · Traditional | GE Healthcare | 08/06/2021SE |
| K211215 | SenoBright HDMUE · Traditional | GE Healthcare | 06/22/2021SE |
| K202902 | 2430MCA with Xmaru WMUE · Traditional | Rayence Co., Ltd. | 06/21/2021SE |
| K192317 | Planmed Clarity 2D and Clarity SMUE · Traditional | Planmed OY | 10/23/2020SE |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY)MUE · Special | Ims Giotto S.P.A. | 06/18/2020SE |
| K193166 | MAMMOMAT RevelationMUE · Traditional | Siemens Medical Solutions USA, Inc. | 06/12/2020SE |
| K193334 | Pristina Serena BrightMUE · Traditional | GE Healthcare | 05/15/2020SE |
| K190809 | Sample Imaging for Senographe PristinaMUE · Traditional | GE Healthcare | 07/29/2019SE |
| K182951 | Pristina Serena 3DMUE · Traditional | GE Healthcare | 01/18/2019SE |
| K173576 | Pristina SerenaMUE · Traditional | GE Healthcare | 05/14/2018SE |
| K173408 | Mammomat RevelationMUE · Traditional | Siemens Medi Cal Solutions, Inc. | 03/21/2018SE |
| K163328 | Planmed ClarityMUE · Traditional | Planmed OY | 12/28/2017SE |
| K172404 | SenoBright HDMUE · Traditional | GE Healthcare | 10/30/2017SE |
| K173132 | ASPIRE CristalleMUE · Special | Fujifilm Medical Systems U.S.A, Inc. | 10/27/2017SE |
| K172027 | Adani MammoScanMUE · Traditional | Adani | 10/20/2017SE |
| K163302 | Senographe PristinaMUE · Traditional | GE Healthcare | 09/01/2017SE |
| K170930 | RSM 2430CMUE · Special | DRTECH Corporation | 04/27/2017SE |
| K162670 | RSM 1824C with RConsole1MUE · Traditional | DRTECH Corporation | 02/23/2017SE |
| K163252 | Mammomat Fusion with Stereotactic BiopsyMUE · Traditional | Siemens Medical Solutions USA, Inc. | 01/10/2017SE |
| K162268 | Senographe PristinaMUE · Traditional | GE Healthcare | 11/03/2016SE |
| K151645 | MAMMOMAT FusionMUE · Traditional | Siemens Medical Solutions USA, Inc. | 09/14/2015SE |
| K133972 | Aspire CristalleMUE · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 03/25/2014SE |
| K130704 | Microdose SiMUE · Traditional | Philips Digital Mammography Sweden AB | 12/13/2013SE |
| K131885 | Senographe Essential, Premium View I (Pvi)MUE · Traditional | GE Medical Systems SCS | 09/26/2013SE |
| K123520 | Mammomat Inspiration PrimeMUE · Traditional | Siemens Medical Solutions USA, Inc. | 06/11/2013SE |
| K122510 | Icrco 3600MMUE · Traditional | Icrco, Inc. | 04/26/2013SE |
| K122286 | Mammomal InspirationMUE · Traditional | Siemens Medical Solutions USA, Inc. | 02/22/2013SE |
| K123995 | Microdose SiMUE · Special | Philips Digital Mammography Sweden AB | 02/01/2013SE |
| K123873 | Contrast Enhanced Digital MammographyMUE · Traditional | Hologic, Inc. | 01/29/2013SE |
| K121963 | Planmed Nuance DigiguideMUE · Traditional | Planmed OY | 11/21/2012SE |
| K121674 | Aspire HD Plus, Aspire Hd-SMUE · Traditional | Fujifilm Medical System U.S.A., Inc. | 09/21/2012SE |
| K120246 | Kodak Directview CR Mammography System (Using Carestream CR Mammography Cassette with…MUE · Traditional | Carestream Health, Inc. | 08/28/2012SE |
| K120255 | Philips MicrodoseMUE · Traditional | Philips Digital Mammography Sweden AB | 04/19/2012SE |
| K110717 | Konica Minolta Xpress Digital Mammography SystemMUE · Traditional | Konica Minolta Medical & Graphic, Inc. | 12/23/2011SE |
| K111324 | CR Mammography System with Dx-M DigitizerMUE · Traditional | Agfa Healthcare N.V. | 12/22/2011SE |
| K110798 | Senographe DS, Senographe EssentialMUE · Traditional | General Electric Company | 12/22/2011SE |
| K111646 | Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General…MUE · Traditional | Fujifilm Medical System U.S.A., Inc. | 12/08/2011SE |
| K111434 | Giotto Image 3D, Giotto Image 3D-LMUE · Traditional | Giotto USA, LLC | 10/27/2011SE |
| K103485 | Senograph DS, Senograph EssenstialMUE · Traditional | General Electric Company | 10/06/2011SE |
| K111361 | Planmed Nuance ExcelMUE · Traditional | Planmeca USA, Inc. | 09/23/2011SE |
| K110572 | Mammodiagnost DRMUE · Traditional | Philips Medical Systems | 09/23/2011SE |
| K110729 | Aspire HD Full-Field Digital Mammography SystemMUE · Traditional | Fujifilm Medical Systems U.S.A, Inc. | 09/01/2011SE |
| K110025 | Sectra Microdose MammographyMUE · Traditional | Sectra Imtec AB | 04/28/2011SE |
PMA approvals
- P080018 Kodak Directview Computed Radiography (CR) Mammography · Carestream Health, Inc. · 11/03/2010
- P050014 Fuji's Computed Radiography Mammography Suite (Fcrms) · Fujifilm Medical System U.S.A., Inc. · 07/10/2006
- P030010 Siemens Mammomat Novationdr Full Field Digital Mammography System · Siemens Medical Solution · 08/20/2004
- P010025 Lorad Digital Breast Imager · Hologic, Inc. · 03/15/2002
- P010017 Senoscan Full Field Digital Mammography System · Hologic, Inc. · 09/25/2001
- P990066 GE Healthcare Senographe Full Field Digital Mammography System · GE Healthcare · 01/28/2000
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2167-2026 Class II | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC…Complaints have been received of systems developing loose, missing, or broken internal bolts over time. | Hologic, Inc | 04/08/2026Open, Classified |
| Z-0879-2026 Class II | MAMMOMAT Fusion;There were instances where the operator table was sold together with a bus-installation kit. The operator… | Siemens Medical Solutions USA, Inc | 10/24/2025Open, Classified |
| Z-0878-2026 Class II | MAMMOMAT Inspiration;There were instances where the operator table was sold together with a bus-installation kit. The operator… | Siemens Medical Solutions USA, Inc | 10/24/2025Open, Classified |
| Z-0877-2026 Class II | MAMMOMAT Revelation;There were instances where the operator table was sold together with a bus-installation kit. The operator… | Siemens Medical Solutions USA, Inc | 10/24/2025Open, Classified |
| Z-0875-2026 Class II | Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and…Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a… | GE Medical Systems, LLC | 10/24/2025Open, Classified |
| Z-0862-2024 Class II | Senographe PristinaX-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not… | GE Medical Systems, SCS | 12/26/2023Open, Classified |
| Z-2388-2020 Class II | MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for…If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum biopsy… | Siemens Medical Solutions USA, Inc | 05/07/2020Terminated |
| Z-1343-2020 Class II | Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions…The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing… | Hologic, Inc. | 01/21/2020Terminated |
| Z-0160-2020 Class II | Mammomat Revelation with software version VC10 and Biopsy Option Intended Use: For…An error can occur when performing a biopsy using the InSpect function. The acquisition workstation may… | Siemens Medical Solutions USA, Inc | 07/23/2019Terminated |
| Z-2132-2019 Class II | GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of…Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | GE Healthcare, LLC | 05/16/2019Terminated |
| Z-2131-2019 Class II | GE Senographe Pristina - Product Usage: Senographe Pristina generates digital…Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | GE Healthcare, LLC | 05/16/2019Terminated |
| Z-0685-2019 Class II | I-View Contrast Enhanced Digital Mammography, ASY-08109Calibration issue not possible to visualize contrast uptake in the subtracted mammography images | Hologic, Inc. | 12/06/2018Terminated |
| Z-0662-2018 Class II | Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed…FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The… | Fujifilm Medical Systems U.S.A., Inc. | 08/04/2017Terminated |
| Z-0661-2018 Class II | ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE…FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The… | Fujifilm Medical Systems U.S.A., Inc. | 08/04/2017Terminated |
| Z-0660-2018 Class II | Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems…FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The… | Fujifilm Medical Systems U.S.A., Inc. | 08/04/2017Terminated |
| Z-0659-2018 Class II | Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR…FUJIFILM Medical Systems U.S.A., Inc. (FMSU) identified a potential failure with our Mammography system. The… | Fujifilm Medical Systems U.S.A., Inc. | 08/04/2017Terminated |
| Z-0386-2018 Class II | ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography…There was a case that the swivel arm went down unintentionally when it was moved up/down. | Fujifilm Medical Systems U.S.A., Inc. | 07/14/2017Terminated |
| Z-0385-2018 Class II | Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR…There was a case that the swivel arm went down unintentionally when it was moved up/down. | Fujifilm Medical Systems U.S.A., Inc. | 07/14/2017Terminated |
| Z-1118-2017 Class II | Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The…Software error | Siemens Medical Solutions USA, Inc | 01/11/2017Terminated |
| Z-2690-2016 Class II | FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner…If an exposure is aborted during a stereo biopsy workflow, an error may occur which would prevent the system… | Fujifilm Medical Systems U.S.A., Inc. | 06/09/2016Terminated |
| Z-1585-2015 Class II | Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A…User Manual lacks a description for handling some errors even though the system can be recovered from such… | Fujifilm Medical Systems U.S.A., Inc. | 02/03/2015Terminated |
| Z-0523-2015 Class II | Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and…It was determined that if the Mammomat Inspiration system is not secured to the floor (per customer request)… | Siemens Medical Solutions USA, Inc | 10/28/2014Terminated |
| Z-0086-2015 Class II | Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is…The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch… | Siemens Medical Solutions USA, Inc | 09/18/2014Terminated |
| Z-1700-2014 Class II | Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030…Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the… | Hologic, Inc. | 05/13/2014Terminated |
| Z-1638-2014 Class II | MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and…There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the… | Siemens Medical Solutions USA, Inc | 04/25/2014Terminated |
| Z-2301-2013 Class II | Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The…Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most… | Hologic, Inc. | 09/06/2013Terminated |
| Z-1787-2014 Class III | Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To…Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots | Beekley Corporation | 06/19/2013Terminated |
| Z-1694-2013 Class II | Siemens Mammomat Inspiration - full-field digital mammography Product Usage: MammographyFirm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that… | Siemens Medical Solutions USA, Inc | 02/28/2013Terminated |
| Z-1519-2013 Class II | GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital…GE Healthcare has recently become aware of a potential issue due to inaccessible Operator Instructions… | GE Healthcare, LLC | 01/14/2013Terminated |
| Z-1642-2014 Class II | MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray…The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part… | Fujifilm Medical System USA, Inc. | 06/29/2012Terminated |
| Z-1063-2012 | GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe…GE Healthcare has become aware of inaccurate measurements on GE magnified images provided by Senographe… | GE Healthcare, LLC | 10/17/2011Terminated |
| Z-0115-2012 | GE SENOGRAPHE DS FULL FIELD DIGITAL ESSENTIAL MAMMOGRAPHY SYSTEM. The Senographe DS…GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS… | GE Healthcare, LLC | 09/22/2011Terminated |
| Z-0114-2012 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL). The Senographe…GE Healthcare has become aware of inaccurate measurement on GE magnified images provided by Senographe DS… | GE Healthcare, LLC | 09/22/2011Terminated |
| Z-0523-2012 | MAMMOMAT Inspiration Full field digital mammographic x-ray systemLowering the swivel arm with "object table" while an operator's or patient's body parts are underneath the… | Siemens Medical Solutions USA, Inc | 09/15/2011Terminated |
| Z-1041-2011 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe…During installation it was discovered that the duplicate of the 21 CFR 1010 Certification label for the… | GE Healthcare, LLC | 01/19/2011Terminated |
| Z-1044-2011 | GE SENOGRAPHE DS FULL FIELD MAMMOGRAPHY SYSTEM MAMMOGRAPHIC FILM / SCREEN SYSTEMIt was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There… | GE Healthcare, LLC | 07/20/2010Terminated |
| Z-1043-2011 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM ( SENO ESSENTIAL) The expected…It was noticed that 3 units received in Japan were missing the rating plate on the X-ray tube cover. There… | GE Healthcare, LLC | 07/20/2010Terminated |
| Z-1233-2009 | Siemens Mammomat Novation DR, full field digital mammography system. Model Number…Image may appear dark, requiring repeat image acquisition. | Siemens Medical Solutions USA, Inc | 01/23/2009Terminated |
| Z-1546-2008 | Selenia Full Field Digital Mammography System with Software v. 3.3.1.1; Full field…Marker Misalignment: The new software version contained a magnification factor that shows CAD markers… | Lorad, A Hologic, Inc. | 02/28/2008Terminated |