NemoFAB
The NemoFAB software is a tool designed for use by specialized dental practices and surgeons for capturing, storing and presenting patient images and supporting the diagnostic process and…
The NemoFAB software is a tool designed for use by specialized dental practices and surgeons for capturing, storing and presenting patient images and supporting the diagnostic process and virtual treatment planning in Orthognathic Surgery procedures. NemoFAB has specific functionalities to visualize the diagnostic information, e.g. from CT-imaging, to perform specific measurements in the image data and to plan surgical actions in order to support the diagnostic and treatment planning process. Based on the CT or CBCT of the skull and the models of the teeth of the patient, the user (an oral and maxillofacial surgeon) designs the treatment plan, moving the osteotomized bones to the appropriate location to fix the bite, the face and/or any other deformities. The module allows the user to import the dental casts in STL format (from a laboratory scanner or intraoral scanner) and merge them to the CT of the patient; this process is necessary if a splint is going to be created. The airway of the patient can be segmented from the CT for analysis purpose and the TMJ (temporomandibular joint) can be studied for supporting the diagnose. Several types of osteotomies are supported: Le Fort 1, Sagittal split, Ramus and Chin. The Arnett/Gunson cephalometric tracing allows the surgeon to have accurate measurements information about the position of the anatomical structures and the extent of the movements; ceph tracing allows the user to digitize anatomical landmarks on a patient’s DICOM (in 3D) or radiograph (in 2D). Arnett/Gunson FAB Cephalometric Analysis performs face, airway and bite analysis, and allows to simulate a treatment plan for orthodontic and surgical cases based on the methodologies of Dr. William Arnett. If the user does not want to follow the protocol of Dr. Arnett, a manual way treatment plan can be simulated. The knowledge of the surgical positions allows this module to create splints for aiding the surgeon in the placement of the bones in the surgery.
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 | Software Nemotec SL |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K192475 |
| Record published | 2026-04-23 |
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 |
|---|---|---|
| 25.0.0.2 | 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
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.