Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Qualisys Clinical System

K-Number: K171547 · 2018-08-02

ApplicantQualisys AB
Decision Date2018-08-02
Product CodeLXJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Qualisys Clinical System is a medical device manufactured by Qualisys AB. It received FDA 510(k) clearance on 2018-08-02 under approval number K171547. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Qualisys Clinical System?

Qualisys Clinical System is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Qualisys AB. The 510(k) number is K171547.

When was Qualisys Clinical System approved by the FDA?

Qualisys Clinical System received FDA 510(k) clearance on 2018-08-02, under approval number K171547.

What company makes Qualisys Clinical System?

Qualisys Clinical System is manufactured by Qualisys AB.

What is the FDA product code for Qualisys Clinical System?

The FDA product code for Qualisys Clinical System is LXJ.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Related Devices (Code: LXJ)

K151955YuGo SystemBiogaming , Ltd. K162748MindMotionPROMindmaze SA K163245Virtual Occupational Therapy Application (VOTA)Barron Associates, Inc. K173931MindMotion(TM) GOMindmaze SA K172882UINCARE HOMEUincare Corp. K192474VERAReflexion Health, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑