SYMBIA 6.0
FDA 510(k) clearance K142006 · decided 2014-08-21
Clearance details
- K-number
- K142006
- Device name
- SYMBIA 6.0
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-23
- Decision date
- 2014-08-21
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hoffman Estates, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of recall (Z-0687-2016) | Siemens Medical Solutions USA, Inc. | 2016-01-21 |
| e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or im recall (Z-0208-2016) | Siemens Medical Solutions USA, Inc. | 2015-11-04 |
| Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- d recall (Z-2435-2015) | Siemens Medical Solutions USA, Inc. | 2015-08-20 |
| Siemens Symbia T Series, a radiological imaging system that is a combination of a single p recall (Z-2436-2015) | Siemens Medical Solutions USA, Inc. | 2015-08-20 |
| Siemens Intevo Series system, a radiological imaging system that is a combination of a sin recall (Z-2437-2015) | Siemens Medical Solutions USA, Inc. | 2015-08-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008) | Siemens Medical Solutions USA, Inc. | 2024-09-23 |
| MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007) | Siemens Medical Solutions USA, Inc. | 2020-08-21 |
| MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006) | Siemens Medical Solutions USA, Inc. | 2019-12-10 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003) | Siemens Medical Solutions USA, Inc. | 2017-03-23 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001) | Siemens Medical Solutions USA, Inc. | 2016-05-12 |
| MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002) | Siemens Medical Solutions USA, Inc. | 2016-01-13 |
| MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011) | Siemens Medical Solutions USA, Inc. | 2015-04-21 |