Joints
The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on…
The Medstrat Joints system is intended to enable the communication, storage, viewing, and manipulation of diagnostic medical images and data. The Joints system can show images on workstations locally and/or across computer networks at widely distributed locations. The Joints software is intended for assisting healthcare professionals in preoperative planning and postoperative evaluation of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and positioning the templates. The typical Joints users are trained professionals such as orthopedic surgeons, referring and collaborating physicians, and authorized medical professionals. It is the user’s responsibility to bear in mind the display monitor’s quality, ambient light conditions, and the tradeoff between image compression ratio and clinical effectiveness for specific image study indications.
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 | Medstrat, United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Manufacturer |
| 510(k) | K051745 |
| Record published | 2022-06-17 |
| Record revised | 2023-10-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5.31 | In distribution | |
| 5.17 | In distribution | |
| 5.13 | In distribution | |
| 5.7 | In distribution | |
| 5.2 | In distribution | |
| 5.16 | In distribution | |
| 5.18 | In distribution | |
| 5.22 | In distribution | |
| 5.15 | In distribution | |
| 5.11 | In distribution | |
| 4.0.23 | In distribution | |
| 4.35 | In distribution | |
| 5.35 | In distribution | |
| 6.3 | In distribution | |
| 5.4 | In distribution | |
| 5.3 | In distribution | |
| 5.30 | In distribution | |
| 4.0.32 | In distribution | |
| 6.10 | In distribution | |
| 6.12 | In distribution | |
| 6.7 | In distribution | |
| 5.8 | In distribution | |
| 5.21 | In distribution | |
| 6.0 | In distribution | |
| 5.23 | In distribution | |
| 5.20 | In distribution | |
| 5.0 | In distribution | |
| 5.33 | In distribution | |
| 5.19 | In distribution | |
| 5.9 | In distribution | |
| 6.11 | In distribution | |
| 5.26 | In distribution | |
| 5.29 | In distribution | |
| 5.37 | In distribution | |
| 4.0.22 | In distribution | |
| 5.32 | In distribution | |
| 6.9 | In distribution | |
| 5.36 | In distribution | |
| 6.4 | In distribution | |
| 5.24 | In distribution | |
| 6.2 | In distribution | |
| 5.34 | In distribution | |
| 5.38 | In distribution | |
| 4.37 | In distribution | |
| 6.5 | In distribution | |
| 5.14 | In distribution | |
| 6.8 | In distribution | |
| 5.28 | In distribution | |
| 4.0.27 | In distribution | |
| 5.12 | In distribution | |
| 6.1 | In distribution | |
| 6.6 | In distribution | |
| 5.1 | In distribution | |
| 5.10 | In distribution | |
| 5.27 | In distribution | |
| 4.0.25 | In distribution | |
| 5.25 | In distribution | |
| 4.0.31 | In distribution | |
| 4.0.30 | In distribution | |
| 4.0.29 | In distribution | |
| 4.0.19 | In distribution | |
| 5.6 | 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 |
| 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 |
|---|---|
| K051745 | 2005-07-14 |
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.