Syngo.plaza
syngo.plaza is picture archiving and communication software for displaying, processing, reading, reporting, sharing and storing medical images. It supports diagnosis and treatment planning…
syngo.plaza is picture archiving and communication software for displaying, processing, reading, reporting, sharing and storing medical images. It supports diagnosis and treatment planning and can integrate with hospital or radiology information systems.
The software supports DICOM structured reports and optional postprocessing applications. It is installed on compatible general-purpose hardware and can distribute images over a network.
Listed Item
syngo.plaza VB20AStock Keeping Unit B – product label DVD Media CoverThis unit contains the following registered Medical Device:(1) syngo.plaza – GTIN 04056869001081
Mammography Conditions
Primary mammography diagnosis requires uncompressed or losslessly compressed, preprocessed DICOM For Presentation images and displays or printers cleared for mammography. Web-based image distribution is not intended for reporting. These conditions limit how the same stored image can be used across viewing workflows.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K132532 |
| Record published | 2016-09-23 |
| Record revised | 2023-10-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11064436 | In distribution | |
| 11064597 | In distribution | |
| 11249952 | In distribution | |
| 11293724 | In distribution | |
| 11249920 | In distribution | |
| 11249915 | In distribution | |
| 11249951 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252608 | 2025-09-09 |
| K240294 | 2024-05-23 |
| K232744 | 2023-12-21 |
| K230561 | 2023-03-21 |
| K230196 | 2023-02-13 |
| K221501 | 2022-10-14 |
| K213665 | 2022-06-21 |
| K201477 | 2020-07-01 |
| K191040 | 2019-05-16 |
| K182208 | 2018-09-07 |
| K180563 | 2018-04-25 |
| K173378 | 2017-11-20 |
| K171053 | 2017-06-01 |
| K161685 | 2016-07-11 |
| K150843 | 2015-04-24 |
| K132532 | 2013-12-09 |
| K123375 | 2012-11-20 |
| K043122 | 2005-02-09 |
| K992925 | 1999-11-23 |
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-02-20 | Class II | Software design | Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. | 92 | 2019-07-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2018-02-20 | Class II | Software design | Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. | 92 | 2019-07-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-08-23 | Class II | Software design | When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The ot | 76 | 2018-10-01 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-08-18 | Class II | Software design | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for | 47 | 2018-08-30 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2017-05-22 | Class II | Software design | Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-arc | 2 units | 2018-07-02 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-09-06 | Class II | Software design | Software upgrade to eliminate several issues | 47 systems | 2017-05-08 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2016-08-02 | Class II | Error in labeling | Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement value ma | 101 Systems | 2017-03-20 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2015-12-22 | Class II | Software design | Siemens is releasing an updated software version to address several software issues including RGB images will show “?” since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is | 68 | 2017-09-05 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2015-02-18 | Class II | Software design | Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived. | 4 | 2016-08-17 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2015-01-13 | Class II | Software Manufacturing/Software Deployment | In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk a | 50 | 2017-02-16 |
| Siemens Medical Solutions USA, Inc. | 510(k) number | 2014-11-11 | Class II | Component design/selection | Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of pri | 149 | 2015-02-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.