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FDA 510(k)

XACT Robotic System

K-Number: K191332 · 2019-10-03

ApplicantXact Robotics, Ltd.
Decision Date2019-10-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XACT Robotic System is a medical device manufactured by Xact Robotics, Ltd.. It received FDA 510(k) clearance on 2019-10-03 under approval number K191332. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XACT Robotic System?

XACT Robotic System is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Xact Robotics, Ltd.. The 510(k) number is K191332.

When was XACT Robotic System approved by the FDA?

XACT Robotic System received FDA 510(k) clearance on 2019-10-03, under approval number K191332.

What company makes XACT Robotic System?

XACT Robotic System is manufactured by Xact Robotics, Ltd..

What is the FDA product code for XACT Robotic System?

The FDA product code for XACT Robotic System is JAK.

Related Clinical Trials

NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT07606963 Triton 1.5 Robotic System for Diagnostic Colonoscopy NOT_YET_RECRUITING NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT07524699 A Study About Remote and Local Liver Surgery NOT_YET_RECRUITING NCT07566767 Effect of Robotic Gait on Functions in Cerebral Palsy COMPLETED

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: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Xact Robotics, Ltd.

K201586XACT Robotic System K213759XACT Robotic System, ACE Model K221116XACT ACE Robotic System

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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.

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