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FDA 510(k)

X-MIND Trium

K-Number: K191719 · 2020-02-20

ApplicantDe Gotzen S.R.L.
Decision Date2020-02-20
Product CodeMUH
Advisory CommitteeDE
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 2020-02-20 under approval number K191719. The device is classified under product code MUH. It was reviewed by the DE 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 2020-02-20. It is manufactured by De Gotzen S.R.L.. The 510(k) number is K191719.

When was X-MIND Trium approved by the FDA?

X-MIND Trium received FDA 510(k) clearance on 2020-02-20, under approval number K191719.

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 MUH.

Other Devices by De Gotzen S.R.L.

K160166X-MIND trium K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) 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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