# K173094: OrthoVision

- Pathway: 510(k) (Special)
- Applicant: Ewoosoft Co., Ltd.
- Decided: Oct 26, 2017 after 27 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: 6 generations back to K930527 (1993). 7 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131570: Orthovision, Ewoosoft Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K192888: EzOrtho (2020), 17 descendants of its own
- K210187: Overjet Dental Assist (2021), 6 descendants of its own
- K202948: EzOrtho (2020), 6 descendants of its own
- K211793: EzOrtho (2021), 5 descendants of its own
- K220003: EzOrtho v1.3 (2022), 4 descendants of its own

## Indications for use
OtrhoVision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation. Results produced by the software’s diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.

Source page: https://510kreport.com/device/K173094
Methodology: https://510kreport.com/methodology