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FDA 510(k)

IMACTIS CT-Navigation system

K-Number: K162314 · 2018-04-24

ApplicantImactis, Sas
Decision Date2018-04-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMACTIS CT-Navigation system is a medical device manufactured by Imactis, Sas. It received FDA 510(k) clearance on 2018-04-24 under approval number K162314. 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 IMACTIS CT-Navigation system?

IMACTIS CT-Navigation system is a medical device that received FDA 510(k) clearance on 2018-04-24. It is manufactured by Imactis, Sas. The 510(k) number is K162314.

When was IMACTIS CT-Navigation system approved by the FDA?

IMACTIS CT-Navigation system received FDA 510(k) clearance on 2018-04-24, under approval number K162314.

What company makes IMACTIS CT-Navigation system?

IMACTIS CT-Navigation system is manufactured by Imactis, Sas.

What is the FDA product code for IMACTIS CT-Navigation system?

The FDA product code for IMACTIS CT-Navigation system is JAK.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Related Devices (Code: JAK)

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Official Source

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

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