MeVis AVM Contour
MeVis AVM Contour supports visualization and contouring of 3D CT-based structures for arteriovenous malformation treatment planning. The software exports contours in DICOM RT Structure Set…
MeVis AVM Contour supports visualization and contouring of 3D CT-based structures for arteriovenous malformation treatment planning.
The software exports contours in DICOM RT Structure Set format for subsequent treatment planning.
Listed Item
MeVis AVM Contour is intended for use by qualified medical professionals working in the field of neurosurgery or radiotherapy planning to manually create target contours for regions of interest in the cranial region through semi-automatic registration of 2D digital subtraction angiography (DSA) images onto 3D computed tomography (CT) scans. The contours can be exported as DICOM RTStruct objects and are used in radiosurgery/-therapy treatment planning procedures to target specific brain regions. The created contours are intended for further review, editing and approval by radiosurgery/-therapy planning specialists in third-party radiosurgery/-therapy treatment planning systems (not part of this submission). The semi-automatic registration is restricted to/requires: • X-ray, 2D DSA and 3D CT images of the brain • X-ray images must be acquired in both frontal and sagittal direction Intended Patient Population MeVis AVM Contour is used for patients diagnosed with Arteriovenous Malformations (AVM) requiring stereotactic radiosurgery (SRS). These patients are adults, 18 years and older. Intended User Profile The intended users are qualified medical professionals, working in the field of neurosurgery or radiotherapy planning (Neurosurgeons and Radiation Oncologists).
Intended Software Role
The filing identifies the intended population as adults aged 18 years and older diagnosed with AVM who require stereotactic radiosurgery. It identifies qualified neurosurgery or radiotherapy professionals as intended users. The filing describes it as a specialized tool for DICOM CT, biplanar X-ray and DSA images.
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 | Mevis Medical Solutions AG, Germany |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K260576 |
| Record published | 2026-07-09 |
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 |
|---|---|---|
| 1.0 | 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 |
|---|---|
| K260576 | 2026-06-30 |
| K120207 | 2012-04-23 |
| K120484 | 2012-03-27 |
| K113701 | 2012-02-16 |
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.