SYNGO US WORKPLACE
FDA 510(k) clearance K060992 · decided 2006-04-28
Clearance details
- K-number
- K060992
- Device name
- SYNGO US WORKPLACE
- Applicant
- Siemens Medical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2006-04-11
- Decision date
- 2006-04-28
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mountainview, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| syngo US Workplace Picture Archiving and Communication System, software version 2.0, Sieme recall (Z-1138-2008) | Siemens Medical Solutions USA, Inc. | 2008-05-20 |