syngo.MI Neurolog
Catalogue number 11431529, listed by Siemens Medical Solutions USA, Inc., United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
1catalogue number
74510(k) clearances naming this product code
40recalls on this code
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 Medical Solutions USA, Inc., United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191309 |
| Record published | 2019-08-12 |
| Record revised | 2021-11-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11431529 | 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 |
|---|---|
| K241569 | 2024-10-11 |
| K230955 | 2023-12-20 |
| K223363 | 2023-01-12 |
| K220832 | 2022-05-20 |
| K212621 | 2021-11-12 |
| K193294 | 2020-07-10 |
| K193290 | 2020-06-17 |
| K201202 | 2020-06-02 |
| K201062 | 2020-05-18 |
| K192462 | 2020-01-31 |
| K182904 | 2019-07-05 |
| K183272 | 2019-02-01 |
| K180336 | 2018-04-19 |
| K173897 | 2018-04-05 |
| K173597 | 2018-04-04 |
| K173611 | 2018-03-16 |
| K170747 | 2017-06-09 |
| K170952 | 2017-04-28 |
| K163294 | 2017-02-06 |
| K163421 | 2017-01-03 |
| K162541 | 2016-11-16 |
| K162339 | 2016-09-21 |
| K160426 | 2016-03-04 |
| K153346 | 2016-03-04 |
| K160317 | 2016-02-29 |
| K151353 | 2015-08-07 |
| K151192 | 2015-06-23 |
| K150192 | 2015-03-29 |
| K143254 | 2014-12-10 |
| K140897 | 2014-07-18 |
| K141554 | 2014-07-11 |
| K133401 | 2014-03-11 |
| K133654 | 2014-02-28 |
| K133644 | 2014-02-25 |
| K130749 | 2013-08-20 |
| K132062 | 2013-07-23 |
| K123420 | 2013-02-01 |
| K123577 | 2013-01-22 |
| K123922 | 2013-01-16 |
| K123528 | 2012-12-20 |
| K121292 | 2012-07-30 |
| K121459 | 2012-06-22 |
| K121074 | 2012-06-08 |
| K120315 | 2012-04-13 |
| K113029 | 2011-11-18 |
| K111052 | 2011-05-20 |
| K110844 | 2011-04-20 |
| K110494 | 2011-04-06 |
| K102150 | 2010-10-05 |
| K100619 | 2010-05-07 |
| K093621 | 2010-02-23 |
| K091373 | 2009-05-20 |
| K083327 | 2009-05-18 |
| K091286 | 2009-05-15 |
| K083149 | 2009-01-14 |
| K071950 | 2007-07-27 |
| K070322 | 2007-02-27 |
| K063826 | 2007-01-12 |
| K053133 | 2005-12-05 |
| K052895 | 2005-10-27 |
| K042868 | 2005-01-06 |
| K042995 | 2004-11-24 |
| K042203 | 2004-09-24 |
| K041484 | 2004-07-30 |
| K030982 | 2003-04-08 |
| K023190 | 2002-10-24 |
| K010938 | 2001-06-26 |
| K992073 | 1999-09-09 |
| K973010 | 1997-11-10 |
| K961871 | 1996-07-31 |
| K955457 | 1996-06-18 |
| K935694 | 1994-03-07 |
| K884621 | 1989-04-26 |
| K870821 | 1987-07-01 |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-27 | Class II | Software design | Functionality in the report sections “Findings Information” and “Summary of Measured Findings” not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The sys | 2020-06-15 | |
| 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 |
| 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 |
| 2018-01-10 | Class II | Software Manufacturing/Software Deployment | When the archiving configuration is changed, data received/created after the upgrade may be flagged as “Not to be archived”. This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Du | 165 units | 2018-10-02 |
| 2018-01-08 | Class II | Software design | A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdat | 236 units | 2020-04-22 |
| 2017-08-31 | Class II | Software Design Change | A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system. | 30 | 2018-10-01 |
| 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 |
| 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 |
| 2017-07-25 | Class II | Software design | Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. | 36 units. | 2018-07-23 |
| 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 |
| 2017-03-06 | Class II | Software design | Software changes now available to address several issues | 104 systems | 2017-06-12 |
| 2017-03-06 | Class II | Software design | Software changes now available to address several issues | 104 | 2017-06-12 |
| 2017-02-20 | Class II | Software design | Software updates | 13 systems | 2017-08-07 |
| 2017-01-11 | Class II | Under Investigation by firm | Software update for improvements and to resolve several issues | 62 systems | 2017-11-16 |
| 2016-09-06 | Class II | Software design | Software upgrade to eliminate several issues | 47 systems | 2017-05-08 |
| 2016-09-06 | Class II | Software design | Software upgrade to eliminate several issues | 47 systems | 2017-05-08 |
| 2016-08-05 | Class II | Software design | Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high. | 338 systems | 2017-08-22 |
| 2016-08-05 | Class II | Software design | Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high. | 338 systems | 2017-08-22 |
| 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 |
| 2016-06-23 | Class II | Software design | Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors. | 50 units | 2020-02-20 |
| 2016-06-06 | Class II | Other | Software issues. Siemens is voluntarily initiating a recall after they became aware of the following system behavior: 1) At times, the view and laterality marker is overlaid by patient demographic information, thus becoming difficult to re | 29 units | 2017-01-17 |
| 2016-05-09 | Class II | Software design | Software error in previous software versions in which two references for the same image may exist in the database. | 74 systems | 2017-03-20 |
| 2016-04-14 | Class II | Software design | Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syngo Dynamics. If the template design has measurements inside a carry forward-configured report section, this will result in carrying forward the | 84 units | 2017-03-20 |
| 2016-02-24 | Class II | Software design | After importing, the segmentation results appear mirrored at the CARTO system and can’t be used for the ablation procedure. | 6 | 2017-02-16 |
| 2016-01-29 | Class II | Software design | Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients. | 151 | 2017-02-16 |
| 2016-01-25 | Class II | Software design | Siemens’ conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics. | 228 units | 2018-06-29 |
| 2016-01-18 | Class II | Software design | To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging. | 49 imaging systems | 2017-08-03 |
| 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 |
| 2015-11-18 | Class II | Software design | Potential post-processing software issue when using tabcard “4D” on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are acquired with a CT scanner with a tilted gantry. In a 2×2 layout, t | 73 units | 2016-12-05 |
| 2015-11-17 | Class II | Software in the Use Environment | For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not released for anatomical print | 42 | 2016-12-05 |
| 2015-10-28 | Class II | Software change control | To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. | 3 | 2016-10-06 |
| 2015-07-06 | Class II | Software design | Potential issue leading to data loss and patient data mix-up | 37 | 2017-01-06 |
| 2015-06-11 | Class II | Software design | During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size. | 5 | 2017-03-24 |
| 2015-05-15 | Class II | Software design | measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print. | 167 | 2017-03-24 |
| 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 |
| 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 |
| 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 |
| 2014-06-30 | Class II | Software design | Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest, Pixel Lens, Edge enhancement | 141 | 2015-02-24 |
| 2014-04-03 | Class II | Use error | A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself. | 64 | 2014-12-15 |
| 2014-04-03 | Class II | Software design | Systems with the affected serial number are experiencing a software error which may lead to incorrect patient demographics display. | 50 | 2014-12-15 |
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.