Synapse Enterprise Viewer
Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting,…
Synapse Enterprise Viewer (EV) is a software-based enterprise image viewer used with general purpose servers and dedicated reading workstations. It allows for communication, reformatting, rendering on the server component and communication and display of DICOM and non-DICOM images as well as reports.
16manufacturers in China registered for this device type
1catalogue number
20recalls 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 | Fujifilm Healthcare Americas Corporation, United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K183248 |
| Record published | 2019-05-23 |
| Record revised | 2022-01-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Synapse Enterprise Viewer | 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
Recalls
18 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 |
|---|---|---|---|---|---|
| 2026-07-22 | Class II | Software design | Software issue may cause the ruler measurement to be inaccurate. | 6 units | |
| 2025-02-11 | Class II | Software change control | The incorrect computed patient age is showing in VX for patients less than 3 months old. | 104 units (69 US, 35 OUS) | |
| 2024-01-10 | Class II | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | 35 Units (28 US, 7 OUS) | |
| 2024-01-10 | Class II | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | 22 units (22 OUS) | |
| 2024-01-10 | Class II | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | 64 Units (44 US, 20 OUS) | |
| 2024-01-10 | Class II | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | 3 Units (3 US) | |
| 2024-01-10 | Class II | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | 12 Units (12 US) | |
| 2024-01-10 | Class II | Software design | Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements. | 19 Units (7 US, 12 OUS) | |
| 2024-01-03 | Class II | Software design | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a pa | 13 | |
| 2024-01-03 | Class II | Software design | The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a pa | 8 | |
| 2021-04-30 | Class II | Software design | Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activi | 44 US and 4 OUS | 2024-07-29 |
| 2021-03-02 | Class II | Software design | The wrong patient information may be displayed in the viewer or PowerJacket. | 839 systems | |
| 2020-12-11 | Class II | Software change control | The software does not update measurements and calculations in the Clinical Reporting Application (CRA) when the ventricular trace is changed in the study by a different user. | 1 unit | 2021-11-17 |
| 2020-09-11 | Class II | Software change control | FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere – other density tools are not affected. | 1 | 2021-11-17 |
| 2020-09-11 | Class II | Device Design | There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality. | 235 | |
| 2020-05-22 | Class II | Software design | Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers may be displayed incorrectly on the 3D TOMO slider bar. In addition, the slice location of the image and/or the slice direction could be incorrect as well, and result in m | 135 units | |
| 2016-09-15 | Class II | Software design | Image data for a patients image may not be correct | 251 units | 2019-02-20 |
| 2016-05-10 | Class II | Software design | Synapse cannot display image files, DICOM SR files, and/or Annotation files. The “Image Not Loaded” message displays instead | 27 units | 2019-02-20 |
| 2006-02-03 | Not classified | Other | Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset. | 179 units | 2012-03-16 |
| 2003-05-12 | Not classified | Other | Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan | 54 units | 2004-05-25 |
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.