# K171547: Qualisys Clinical System

- Pathway: 510(k) (Traditional)
- Applicant: Qualisys AB
- Decided: Aug 2, 2018 after 433 days
- Product code: LXJ (Interactive Rehabilitation Exercise Devices)
- Device class: 2
- Regulation: 21 CFR 890.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890076 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131660: Smart (Smart-D, Smart-DX), Bts S.P.A. (2014) Summary page 5.

## Indications for use
The Qualisys Clinical System is a camera and computer system used to quantify and graphically display human movement patterns for adults and children. It is intended to be used for movement analysis in the fields of gait analysis, rehabilitation, sports medicine and ergonomics.

Source page: https://510kreport.com/device/K171547
Methodology: https://510kreport.com/methodology