510(k) · Cleared
ClearedQualisys Clinical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qualisys AB · LXJ Interactive Rehabilitation Exercise Devices
Cleared on Aug 2, 2018 as substantially equivalent to K131660 (Bts S.P.A., 2014) after a 433-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Aug 2, 2018
- Review
- 433 days
- Class
- Class II
- Product code
- LXJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K890076 (1989). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK890076 OrthotrakMotion Analysis Corp. · 1989
- 3 generations backK982425 Coda MPX30 Motion Analysis SystemPinsco Inc. Dba B & L Engineering · 1998
- 2 generations backK030714 Peak MotusPeak Performance Technologies, Inc. · 2003
- 1 generation backK131660 Smart (Smart-D, Smart-DX)Bts S.P.A. · 2014
- This deviceK171547 Qualisys Clinical SystemQualisys AB · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890076 | Orthotrak | Motion Analysis Corp. | 1989 | — |
| −3 | K982425 | Coda MPX30 Motion Analysis System | Pinsco Inc. Dba B & L Engineering | 1998 | — |
| −2 | K030714 | Peak Motus | Peak Performance Technologies, Inc. | 2003 | — |
| −1 | K131660 | Smart (Smart-D, Smart-DX) | Bts S.P.A. | 2014 | — |
| 0 (this device) | K171547 | Qualisys Clinical System | Qualisys AB | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LXJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131660 | Smart (Smart-D, Smart-DX)Summary page 5…redicate Device Name SMART-D Manufacturer BTS SPA, Via della Croce Rossa 11, PD Italy 35129 510(k) Number K131660 Product Code LXJ Device Class 2 Regulation Number 890.5360 Review Panel Physical Medicine… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 9.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All LXJ devicesLXJ Interactive Rehabilitation Exercise Devices: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LXJ
3in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LXJ
224in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LXJ
No recall names LXJ since 2007.
Adverse event reports per year · LXJ
1in 2018
MAUDE reports naming product code LXJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 182 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 231 | 0 | 1 |
| 2019 | 3 | 224 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171547: Qualisys Clinical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171547
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026