# K260716: Neowise

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: May 4, 2026 after 60 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
Longest line of descent: 8 generations back to K954678 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200572: Planmeca Romexis, Planmeca Oy (2020) Summary page 6.

## Indications for use
Neowise is a medical imaging software intended for use in dental and medical applications as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to elaborate (retrieve, process, render, diagnose, review, and for non-medical application as store, print and distribute) images of both adults and pediatric patients. Neowise is also software for simulating treatment options. Neowise is also intended to be used for monitoring, recording, storing and displaying mandibular jaw position related to maxilla. The software is for use by authorized healthcare professionals. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery.

Source page: https://510kreport.com/device/K260716
Methodology: https://510kreport.com/methodology