Advanced Visualization Workspace
Advanced Visualization Workspace is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows…
Advanced Visualization Workspace is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
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 |
| 510(k) | K162025 |
| Record published | 2023-01-19 |
| Record revised | 2025-04-30 (version 5) |
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 |
|---|---|---|
| Advanced Visualization Workspace – 15 | In distribution | |
| Advanced Visualization Workspace – 15 | In distribution | |
| Advanced Visualization Workspace – 15 | 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
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.