SurgiCase Viewer
SurgiCase Viewer is software for visualizing three-dimensional data and communicating about treatment options. Medical professionals can inspect the models and take measurements to help…
SurgiCase Viewer is software for visualizing three-dimensional data and communicating about treatment options. Medical professionals can inspect the models and take measurements to help evaluate a proposed treatment. When reviewing or validating treatment options, they use the viewer alongside other diagnostic tools and clinical judgment.
A device manufacturer, service provider or hospital department can also use the viewer to show a proposed device or intermediate manufacturing stage to the clinician ordering it. The clinician can evaluate the displayed models and provide feedback during that process.
Model Data
The viewer imports dedicated formats containing STL models and additional model information. It displays the imported three-dimensional data without altering it and integrates with an online system that manages cases and user access.
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 | Materialise NV, Belgium |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K170419 |
| Record published | 2017-06-16 |
| Record revised | 2025-03-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SurgiCase 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251964 | 2026-03-12 |
| K223427 | 2024-05-31 |
| K233217 | 2024-02-12 |
| K213684 | 2022-06-15 |
| K190874 | 2019-06-05 |
| K183105 | 2019-03-27 |
| K173619 | 2018-03-21 |
| K170419 | 2017-05-11 |
| K113599 | 2012-04-27 |
| K111641 | 2011-09-26 |
| K073449 | 2008-04-16 |
| K073468 | 2008-04-02 |
| K060950 | 2006-05-18 |
| K053592 | 2006-02-08 |
| K033849 | 2004-05-25 |
| K970617 | 1997-04-21 |
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.