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FDA 510(k)

X-MIND trium

K-Number: K160166 · 2016-11-15

ApplicantDe Gotzen S.R.L.
Decision Date2016-11-15
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-MIND trium is a medical device manufactured by De Gotzen S.R.L.. It received FDA 510(k) clearance on 2016-11-15 under approval number K160166. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-MIND trium?

X-MIND trium is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by De Gotzen S.R.L.. The 510(k) number is K160166.

When was X-MIND trium approved by the FDA?

X-MIND trium received FDA 510(k) clearance on 2016-11-15, under approval number K160166.

What company makes X-MIND trium?

X-MIND trium is manufactured by De Gotzen S.R.L..

What is the FDA product code for X-MIND trium?

The FDA product code for X-MIND trium is OAS.

Other Devices by De Gotzen S.R.L.

K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) K191719X-MIND Trium K192165Acteon Imaging Suite

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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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