Product code MUE
- Device name
- Full Field Digital, System, X-Ray, Mammographic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1715
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P080018S001 | KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE | Carestream Health, Inc. | 2010-12-01 |
| P010025S019 | HOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2010-11-16 |
| P990066S037 | GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2010-11-05 |
| P030010S006 | SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM | Siemens Medical Solution | 2010-11-05 |
| P080018 | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY | Carestream Health, Inc. | 2010-11-03 |
| P030010S005 | SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM | Siemens Medical Solution | 2010-10-06 |
| P010025S020 | HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2010-09-07 |
| P990066S036 | GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2010-05-27 |
| P990066S035 | GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2010-05-20 |
| P010025S018 | SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2010-03-04 |
| P010025S017 | SELENIA DIMENSIONS 2D MOBILE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2009-12-23 |
| P990066S034 | GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2009-11-24 |
| P050014S002 | FULL FIELD DIGITAL MAMMOGRAPHY | Fujifilm Medical System U.S.A., Inc. | 2009-08-11 |
| P990066S033 | GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2009-07-10 |
| P030010S004 | MAMMOMAT NOVATION DR | Siemens Medical Solution | 2009-06-04 |
| P010025S016 | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2009-05-01 |
| P010025S015 | HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2009-03-16 |
| P050014S001 | FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE | Fujifilm Medical System U.S.A., Inc. | 2009-01-09 |
| P010025S013 | SELENIA DIMENSIONS (2D) FFDM SYSTEM | Hologic, Inc. | 2008-12-22 |
| P990066S032 | GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2008-07-30 |
| P990066S031 | GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2008-07-16 |
| P990066S030 | GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2008-05-27 |
| P010025S012 | HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2008-05-23 |
| P990066S029 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL | GE Healthcare | 2007-08-01 |
| P010025S010 | HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2007-06-01 |
| P990066S028 | SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS | GE Healthcare | 2007-04-13 |
| P990066S027 | SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | GE Healthcare | 2007-04-13 |
| P010025S009 | HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2007-01-17 |
| P990066S026 | SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS | GE Healthcare | 2007-01-03 |
| P990066S025 | SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS | GE Healthcare | 2006-10-20 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | GE Medical Systems SCS | 2026-03-24 |
| K243420 | HESTIA | Genoray Co., Ltd. | 2025-07-17 |
| K243849 | 2430TCA with Xmaru W | Rayence Co., Ltd. | 2025-03-12 |
| K241113 | VIVIX-M | Vieworks Co., Ltd. | 2025-01-16 |
| K233539 | MAMMOMAT B.brilliant | Siemens Medical Solutions USA, Inc. | 2024-03-27 |
| K220073 | RMF-2000 | DRTECH Corporation | 2023-01-26 |
| K211720 | Planmed Clarity 2D, Planmed Clarify S | Planmed OY | 2022-07-18 |
| K212873 | Aspire Cristalle | Fujifilm Corporation | 2022-05-27 |
| K210151 | Digimamo D | Vmi Tecnologias Ltda | 2022-03-01 |
| K202822 | Helianthus | Metaltronica Spa | 2021-12-15 |
| K211725 | Senographe Pristina | GE Healthcare | 2021-08-06 |
| K211215 | SenoBright HD | GE Healthcare | 2021-06-22 |
| K202902 | 2430MCA with Xmaru W | Rayence Co., Ltd. | 2021-06-21 |
| K192317 | Planmed Clarity 2D and Clarity S | Planmed OY | 2020-10-23 |
| K200424 | Giotto Class (Models - 3000X-YY and 4000X-YY) | Ims Giotto S.P.A. | 2020-06-18 |
| K193166 | MAMMOMAT Revelation | Siemens Medical Solutions USA, Inc. | 2020-06-12 |
| K193334 | Pristina Serena Bright | GE Healthcare | 2020-05-15 |
| K190809 | Sample Imaging for Senographe Pristina | GE Healthcare | 2019-07-29 |
| K182951 | Pristina Serena 3D | GE Healthcare | 2019-01-18 |
| K173576 | Pristina Serena | GE Healthcare | 2018-05-14 |
| K173408 | Mammomat Revelation | Siemens Medi Cal Solutions, Inc. | 2018-03-21 |
| K163328 | Planmed Clarity | Planmed OY | 2017-12-28 |
| K172404 | SenoBright HD | GE Healthcare | 2017-10-30 |
| K173132 | ASPIRE Cristalle | Fujifilm Medical Systems U.S.A, Inc. | 2017-10-27 |
| K172027 | Adani MammoScan | Adani | 2017-10-20 |
| K163302 | Senographe Pristina | GE Healthcare | 2017-09-01 |
| K170930 | RSM 2430C | DRTECH Corporation | 2017-04-27 |
| K162670 | RSM 1824C with RConsole1 | DRTECH Corporation | 2017-02-23 |
| K163252 | Mammomat Fusion with Stereotactic Biopsy | Siemens Medical Solutions USA, Inc. | 2017-01-10 |
| K162268 | Senographe Pristina | GE Healthcare | 2016-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278866899 | not applicable | GE MEDICAL SYSTEMS | 2024-06-07 |
| 00195278719812 | not applicable | GE MEDICAL SYSTEMS | 2024-04-11 |
| 00195278655141 | not applicable | GE MEDICAL SYSTEMS | 2023-07-28 |
| 00195278716026 | not applicable | GE MEDICAL SYSTEMS | 2023-07-05 |
| 08056977360007 | GIOTTO CLASS | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360014 | GIOTTO CLASS | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360038 | GIOTTO CLASS | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360045 | GIOTTO CLASS | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360052 | GIOTTO CLASS | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360069 | GIOTTO IMAGE | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360076 | GIOTTO IMAGE | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360083 | GIOTTO IMAGE | IMS GIOTTO SPA | 2021-03-23 |
| 08056977360106 | MAMMOBED | IMS GIOTTO SPA | 2021-03-23 |
| 00840682146845 | not applicable | GE MEDICAL SYSTEMS | 2021-02-16 |
| 00195278009289 | not applicable | GE MEDICAL SYSTEMS | 2020-07-08 |
| 00840682122603 | not applicable | GE MEDICAL SYSTEMS | 2017-09-13 |
| 08033837190028 | GIOTTO IMAGE 3DL | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 08033837190059 | GIOTTO IMAGE 3DL | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 08033837190042 | GIOTTO IMAGE 3DL | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 08033837190011 | GIOTTO IMAGE 3DL | I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL | 2016-09-22 |
| 40889971790312 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971941509 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889978156180 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889978188341 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889978336193 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889978792128 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971667577 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971508276 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971342863 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |
| 40889971290386 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | CARESTREAM HEALTH, INC. | 2016-09-16 |