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…

Registry build 21.09.26

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.

16manufacturers in China registered for this device type
1catalogue number

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.

Chinese manufacturers registered for FDA product code LLZ
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

Regulatory record for NemoFAB
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

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for NemoFAB
Catalogue number Size Status
25.0.0.2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imagegrid Radiology Viewer System Candelis, Inc. 173
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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer