# K183695: OrthoAnalysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Inteware Co., Ltd.
- Decided: Sep 12, 2019 after 255 days
- Product code: PNN (Orthodontic Software)
- Device class: 2
- Regulation: 21 CFR 872.5470
- 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
OrthoAnalysis software is designed for use as a medical device providing tools for orthodontic model design and export, inspection, analysis and treatment simulation. The use of the OrthoAnalysis software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Source page: https://510kreport.com/device/K183695
Methodology: https://510kreport.com/methodology