SYNGO.PLAZA VB10A
FDA 510(k) clearance K132532 · decided 2013-12-09
Clearance details
- K-number
- K132532
- Device name
- SYNGO.PLAZA VB10A
- Applicant
- Siemens AG Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2013-08-12
- Decision date
- 2013-12-09
- Days to decision
- 119 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.plaza VB10A, Picture Archiving and Communication System recall (Z-2892-2016) | Siemens Medical Solutions USA, Inc | 2016-09-27 |
| Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, re recall (Z-2794-2016) | Siemens Medical Solutions USA, Inc | 2016-09-14 |
| Syngo Plaza Picture archiving and communication system. Software only. PACS intended to di recall (Z-0862-2016) | Siemens Medical Solutions USA, Inc | 2016-02-23 |
| Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, proc recall (Z-1354-2015) | Siemens Medical Solutions USA, Inc | 2015-03-30 |
| Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended t recall (Z-1027-2015) | Siemens Medical Solutions USA, Inc | 2015-01-28 |
| Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Pic recall (Z-0576-2015) | Siemens Medical Solutions USA, Inc | 2014-12-15 |