MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
FDA premarket approval P140011/S001 · decided 2016-05-12
Approval details
- PMA number
- P140011
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
- Generic name
- Digital breast tomosynthesis
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2015-11-23
- Decision date
- 2016-05-12
- Days to decision
- 171 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- Approval for change to the indications for use statement. The device, as modified, will be marketed under the trade name MAMMOMAT Inspiration with Tomosynthesis Option and is indicated for acquisition of 2D as well as 3D digital mammography images to be used in screening and diagnosis of breast cancer. A screening examination may consist of a 3D DBT image set and/or a 2D FFDM image set.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| syngo.CT Coronary Cockpit (K253786) | Siemens Medical Solutions USA, Inc. | 2026-06-25 |
| MAMMOMAT B.brilliant (11372950) (K253678) | Siemens Medical Solutions USA, Inc. | 2026-06-18 |
| ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844) | Siemens Medical Solutions USA, Inc. | 2026-06-16 |
| Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family (K261315) | Siemens Medical Solutions USA, Inc. | 2026-05-21 |
| syngo Application Software (K254184) | Siemens Medical Solutions USA, Inc. | 2026-04-29 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |