SYNGO DYNAMICS, VERSION 9.0
FDA 510(k) clearance K102150 · decided 2010-10-05
Clearance details
- K-number
- K102150
- Device name
- SYNGO DYNAMICS, VERSION 9.0
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-07-29
- Decision date
- 2010-10-05
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Ann Arbor, MI, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended f recall (Z-0826-2016) | Siemens Medical Solutions USA, Inc | 2016-02-19 |
| Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended f recall (Z-1613-2014) | Siemens Medical Solutions USA, Inc | 2014-05-13 |
| syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, recall (Z-1216-2014) | Siemens Medical Solutions USA, Inc | 2014-03-18 |
| syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system recall (Z-1859-2013) | Siemens Medical Solutions USA, Inc | 2013-08-01 |
| syngo Dynamics Version 9.5 recall (Z-2219-2012) | Siemens Medical Solutions, USA, Inc | 2012-08-17 |
| syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI. The syngo recall (Z-2293-2011) | Siemens Medical Solutions, USA, Inc | 2011-05-25 |
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 |