510(k) K093612 ยท LLZ System, Image Processing, Radiological
SYNGO.PLAZA
| Applicant | Siemens AG Medical Solutions, Erlangen, DE |
| Decision | Substantially Equivalent, Mar 4, 2010 |
| Received | Nov 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 10, 2017 | Siemens Medical Solutions USA, Inc Syngo.plaza, Picture Archiving and Communications System (PACS)
Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, Terminated |
LLZ | None listed |
| Jan 11, 2017 | Siemens Medical Solutions USA, Inc Syngo.plaza, picture archiving and communications system. Terminated |
LLZ | None listed |
| Sep 27, 2016 | Siemens Medical Solutions USA, Inc Syngo.plaza, Picture Archiving and Communication System Terminated |
LLZ | None listed |
| Sep 14, 2016 | Siemens Medical Solutions USA, Inc Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Terminated |
LLG | None listed |
| Jun 29, 2016 | Siemens Medical Solutions USA, Inc Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173, Terminated |
LLZ | None listed |
| Feb 23, 2016 | Siemens Medical Solutions USA, Inc Syngo Plaza Picture archiving and communication system.
Software only.
PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and ar Terminated |
LLZ | None listed |
| Sep 2, 2015 | Siemens Medical Solutions USA, Inc Syngo.plaza; picture archiving and communications system
Product Usage:
Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, dis Terminated |
LLZ | None listed |
| Mar 30, 2015 | Siemens Medical Solutions USA, Inc Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physic Terminated |
LLZ | None listed |
| Jan 28, 2015 | Siemens Medical Solutions USA, Inc Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It suppo Terminated |
LLZ | None listed |
| Dec 15, 2014 | Siemens Medical Solutions USA, Inc Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS :
Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, di Terminated |
LLZ | None listed |
| Nov 13, 2013 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza image processing system
image processing radiological system Terminated |
LLZ | None listed |
| Aug 15, 2013 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza SW version VA20 with Mammography license.
image processing, radiological system Terminated |
LLZ | None listed |
| Dec 3, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza Radiological Image Processing System
Usage: Radiological Image Processing System Terminated |
LLZ | None listed |
| Oct 11, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza radiological image processing system. Terminated |
LLZ | None listed |
| Feb 29, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza with software version VA20B_HF04
Product Usage:
Radiological image processing system Terminated |
LLZ | None listed |
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc syngo.plaza
Image processing system Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.