Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option
FDA premarket approval P140011/S005 · decided 2017-09-29
Approval details
- PMA number
- P140011
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option
- Generic name
- Digital breast tomosynthesis
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2017-08-21
- Decision date
- 2017-09-29
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- Approval for a change to the detector, updated detector (LMAM2V2) with new electronic circuits for read-out.
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 |