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FDA 510(k)

3D Visualization System

K-Number: K183675 · 2019-09-25

ApplicantScivita Medical Technology Co., Ltd.
Decision Date2019-09-25
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

3D Visualization System is a medical device manufactured by Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-09-25 under approval number K183675. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D Visualization System?

3D Visualization System is a medical device that received FDA 510(k) clearance on 2019-09-25. It is manufactured by Scivita Medical Technology Co., Ltd.. The 510(k) number is K183675.

When was 3D Visualization System approved by the FDA?

3D Visualization System received FDA 510(k) clearance on 2019-09-25, under approval number K183675.

What company makes 3D Visualization System?

3D Visualization System is manufactured by Scivita Medical Technology Co., Ltd..

What is the FDA product code for 3D Visualization System?

The FDA product code for 3D Visualization System is GCJ.

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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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