Vue PACS (Diagnostic)
The Vue PACS diagnostic client is web deployable and has a variety of user profiles applicable to different stakeholder in the cycle of care such as radiologists, referring physicians,…
The Vue PACS diagnostic client is web deployable and has a variety of user profiles applicable to different stakeholder in the cycle of care such as radiologists, referring physicians, technologists etc. With advanced streaming technology, the Vue PACS diagnostic client can perform well even over slow communication lines between the client and the server. Enterprise workflow capabilities allow users across the network to read and report from a global worklist, irrespective of the image acquisition location. The Vue Diagnostic workstation includes native clinical applications such as Lesion Management, CT Perfusion, MR Perfusion/Diffusion.
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 | Philips Medical Systems Nederland B.V., Netherlands |
|---|---|
| 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, Exporter |
| Record published | 2020-05-18 |
| Record revised | 2026-01-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Vue PACS (Diagnostic) – 12 | 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 |
|---|---|
| K251215 | 2025-10-02 |
| K250181 | 2025-07-15 |
| K242512 | 2024-10-24 |
| K221270 | 2022-05-31 |
| K201573 | 2021-08-17 |
| K200713 | 2020-04-09 |
| K181177 | 2018-05-31 |
| K173467 | 2017-12-12 |
| K163250 | 2017-05-11 |
| K162484 | 2017-02-23 |
| K162955 | 2016-12-19 |
| K160315 | 2016-02-19 |
| K130278 | 2013-05-29 |
| K121296 | 2013-01-02 |
| K121781 | 2012-10-26 |
| K111245 | 2011-07-29 |
| K083740 | 2009-02-13 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips Medical Systems Technologies Ltd | UDI-DI | 2024-10-10 | Class II | Software design | A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorre | 2439 systems |
Recalls
5 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 |
|---|---|---|---|---|
| 2026-03-19 | Class II | Labeling design | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion f | 1,033 units |
| 2026-03-05 | Class II | Software design | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. | 3,552 units |
| 2025-08-08 | Class II | Software design | Software issue that results in the display of outdated information. | 4 units |
| 2025-04-07 | Class II | Software in the Use Environment | An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report. | 996 units (267 US, 729 OUS) |
| 2024-04-04 | Class II | Software design | Study data is not able to be archived, copied, or exported with the cardiovascular software version. | 139 |
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.