Product code OTE
- Device name
- Digital Breast Tomosynthesis
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P080003S011 | Envision Mammography Platform | Hologic, Inc. | 2025-11-24 |
| P130020S005 | Senographe Pristina 3D | GE Healthcare | 2025-11-21 |
| P140011S008 | MAMMOMAT B.brilliant with Tomosynthesis Option | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| P080003S009 | Envision Mammography Platform | Hologic, Inc. | 2024-07-05 |
| P080003S010 | Selenia Dimensions/3Dimensions | Hologic, Inc. | 2024-05-29 |
| P160031S004 | ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option | Fujifilm Medical Systems U.S.A, Inc. | 2023-02-13 |
| P130020S004 | Senographe Pristina 3D and SenoClaire | GE Healthcare | 2021-03-23 |
| P160031S003 | ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option | Fujifilm Medical Systems U.S.A, Inc. | 2020-09-30 |
| P140011S007 | MAMMOMAT Revelation with Tomosynthesis Option System | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| P140011S006 | MAMMOMAT Revelation with Tomosynthesis Option | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| P160031S002 | Aspire Cristalle Digital Breast Tomosynthesis Option | Fujifilm Medical Systems U.S.A, Inc. | 2019-10-25 |
| P080003S008 | Selenia Dimensions 3D System High Resolution Tomosynthesis | Hologic, Inc. | 2019-10-24 |
| P160031S001 | ASPIRE Cristalle Breast Tomosynthesis System | Fujifilm Medical Systems U.S.A, Inc. | 2019-02-08 |
| P080003S007 | Selenia Dimensions / 3Dimensions | Hologic, Inc. | 2018-06-22 |
| P080003S006 | Selenia Dimensions/3Dimensions 3D System | Hologic, Inc. | 2018-03-23 |
| P130020S003 | Senographe Pristina 3D | GE Healthcare | 2017-12-28 |
| P140011S005 | Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| P080003S005 | Selenia Dimensions 3D System. | Hologic, Inc. | 2017-05-23 |
| P080003S004 | 3Dimensions | Hologic, Inc. | 2017-04-20 |
| P140011S003 | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| P130020S002 | SENOGRAPHE PRISTINA 3D | GE Healthcare | 2017-03-03 |
| P160031 | ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION | Fujifilm Medical Systems U.S.A, Inc. | 2017-01-10 |
| P130020S001 | SENOCLAIRE | GE Healthcare | 2017-01-05 |
| P080003S003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2016-07-07 |
| P140011S001 | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| P140011S002 | MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| P140011 | MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION | Siemens Medical Solutions USA, Inc. | 2015-04-21 |
| P130020 | SENOCLAIRE | GE Healthcare | 2014-08-26 |
| P080003S001 | SELENIA DIMENSIONS 3D SYSTEM | Hologic, Inc. | 2013-05-16 |
| P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. | 2011-02-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15420045518230 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518223 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518216 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518193 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518186 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518131 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518148 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518155 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518162 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 15420045518179 | Selenia® Dimensions® | Hologic, Inc. | 2026-03-12 |
| 00198953109281 | Senographe Pristina | GE MEDICAL SYSTEMS | 2025-12-01 |
| 10198953054311 | not applicable | GE MEDICAL SYSTEMS | 2025-11-28 |
| 15420045516274 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516366 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516359 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516342 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516335 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516328 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516311 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516304 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516281 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516267 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516250 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516243 | Envision | Hologic, Inc. | 2025-11-13 |
| 15420045516236 | Envision | Hologic, Inc. | 2025-11-13 |
| 00195278914026 | Senographe Pristina | GE MEDICAL SYSTEMS | 2025-01-09 |
| 10195278901764 | Not Applicable | GE MEDICAL SYSTEMS | 2025-01-09 |
| 00195278795724 | not applicable | GE MEDICAL SYSTEMS | 2024-01-22 |
| 00195278711229 | not applicable | GE MEDICAL SYSTEMS | 2023-09-14 |
| 00195278560049 | not applicable | GE MEDICAL SYSTEMS | 2022-12-01 |