RamSoft
PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage,…
PowerServer is a scalable storage and distribution system for clinical images and data. Images can be stored in lossless or lossy formats. The system is DICOM compliant for image storage, archiving, retrieval, and transmission, and communicates with other DICOM devices. The system also communicates with PowerReader workstations and PowerCache servers. Acquired image data is preserved as captured and changes to display definitions are saved as presentation states so that images may always be reverted back to their initial state. PowerCache is a caching server that communicates with PowerServer and serves PowerReader workstations. A single PowerCache can serve multiple PowerReader workstations, reducing network traffic between PowerReader workstations and PowerServer. PowerReader is a workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data stored on PowerServer and PowerCache. PowerReader can connect directly to PowerServer and can also connect via PowerCache. PowerReader provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data. Gateway is a stand-alone DICOM compliant workstation that views, edits, manipulates, annotates, analyzes, stores, and distributes images and data. Gateway provides the user with the ability to import, transmit, print, display, store, edit, and process medical images and data
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 | Ramsoft, Inc., Canada |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K052460 |
| Record published | 2019-11-07 |
| Record revised | 2023-10-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6.0.9.9110 | In distribution | |
| 6.0.11.11031A | In distribution | |
| 6.0.11.11031 | In distribution | |
| 6.0.8.8111 | In distribution | |
| 3.0 | In distribution | |
| 6.0.10.10100 | In distribution | |
| 6.0.5.5100 | In distribution | |
| 6.0.7.7115 | In distribution | |
| 6.0.9.9060 | In distribution | |
| 202505 | In distribution | |
| 6.0.9.9061 | In distribution | |
| 6.0.9.9061 | In distribution | |
| 6.0.10.10100 | In distribution | |
| 6.0.5.5100 | In distribution | |
| 202601 | In distribution | |
| 6.0.5.5040 | In distribution | |
| 6.0.7.7115 | In distribution | |
| 202507 | In distribution | |
| 202411 | In distribution | |
| 6.0.11.11031 | In distribution | |
| 6.0.5.5100 | In distribution | |
| 1.0 | In distribution | |
| 202407 | In distribution | |
| 6.0.6.6015 | In distribution | |
| 6.0.7.7115 | In distribution | |
| 6.0.8.8111 | In distribution | |
| 6.0.9.9060 | In distribution | |
| 6.0.10.10100 | In distribution | |
| 6.0.5.5040 | In distribution | |
| 6.0.11.11031 | In distribution | |
| 202510 | In distribution | |
| 202603 | In distribution | |
| 2.0 | In distribution | |
| 6.0.9.9110 | In distribution | |
| 6.0.9.9061 | In distribution | |
| 6.0.6.6015 | In distribution | |
| 6.0.5.5040 | In distribution | |
| 6.0.6.6015 | In distribution | |
| 6.0.9.9061 | In distribution | |
| 6.0.6.6015 | In distribution | |
| 6.0.7.7221 | In distribution | |
| 6.0.7.7221 | In distribution | |
| 6.0.8.8111 | In distribution | |
| 202605 | In distribution | |
| 6.0.5.5100 | In distribution | |
| 6.7.0.49 | In distribution | |
| 6.0.11.11031A | In distribution | |
| 6.0.11.11031B | In distribution | |
| 6.0.7.7221 | In distribution | |
| 6.0.11.11031A | In distribution | |
| 6.0.10.10100 | In distribution | |
| 6.0.11.11031B | In distribution | |
| 6.0.7.7221 | In distribution | |
| 6.0.11.11031 | In distribution | |
| 6.0.8.8111 | In distribution | |
| 6.0.5.5040 | In distribution | |
| 6.0.9.9110 | In distribution | |
| 6.0.11.11031B | In distribution | |
| 6.0.7.7115 | In distribution | |
| 6.7.0.49 | In distribution | |
| 6.0.9.9060 | In distribution | |
| 202408 | In distribution | |
| 6.0.9.9110 | In distribution | |
| 6.0.9.9060 | In distribution | |
| 6.7.0.49 | 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 |
| 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 |
| VSP System | 3D Systems, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222476 | 2022-11-17 |
| K141881 | 2014-10-31 |
| K052460 | 2005-09-21 |
| K031562 | 2003-08-11 |
| K982563 | 1998-10-06 |
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.