# K192475: NemoFAB

- Pathway: 510(k) (Traditional)
- Applicant: Software Nemotec S.L.
- Decided: Apr 23, 2020 after 226 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
NemoFAB is a software indicated for supporting the diagnostic and treatment planning process of orthognathic procedures. NemoFAB is software that is also used as an image segmentation system and for the transfer of imaging information from a scanner such as a CT scanner. NemoFAB allows for the creation of a file that can be transferred to a 3D printer for the creation of a splint, this splint will be used for aiding the surgeon in the placement of the bones in the orthognathic surgery according to the treatment plan.

Source page: https://510kreport.com/device/K192475
Methodology: https://510kreport.com/methodology