MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
FDA premarket approval P140011 · decided 2015-04-21
Approval details
- PMA number
- P140011
- Trade name
- MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION
- Generic name
- Digital breast tomosynthesis
- Applicant
- Siemens Medical Solutions USA, Inc.
- Date received
- 2014-06-26
- Decision date
- 2015-04-21
- Days to decision
- 299 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Mavern, PA
- Statement
- APPROVAL FOR THE MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION. THIS DEVICE IS INDICATED FOR THE ACQUISITION OF 2D AS WELL AS 3D DIGITAL MAMMOGRAPHY IMAGES TO BE USED IN SCREENING AND DIAGNOSIS OF BREAST CANCER. EACH SCREENING EXAMINATION MAY CONSIST OF CC AND MLO VIEWS IN: A 2D IMAGE SET, OR A 2D AND 3D IMAGE SET. NOTE: THE SCREENING EXAMINATION MAY CONSIST OF 2D FFDM IMAGES SET WITH OR WITHOUT THE 3D IMAGE SET.
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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 |