SYNGO.X
FDA 510(k) clearance K092519 · decided 2009-08-27
Clearance details
- K-number
- K092519
- Device name
- SYNGO.X
- Applicant
- Siemens AG Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2009-08-18
- Decision date
- 2009-08-27
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Erlangen, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Syngo.x, Picture archiving and communication system Syngo via is a software solution inten recall (Z-1688-2017) | Siemens Medical Solutions USA, Inc | 2017-03-27 |
| Syngo.x picture archiving and communication system Syngo.x is a software solution intended recall (Z-2852-2016) | Siemens Medical Solutions USA, Inc | 2016-09-21 |
| Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, recall (Z-1705-2015) | Siemens Medical Solutions USA, Inc | 2015-06-03 |