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FDA 510(k)

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

K-Number: K201382 · 2020-11-18

ApplicantDe Gotzen S.R.L.
Decision Date2020-11-18
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is a medical device manufactured by De Gotzen S.R.L.. It received FDA 510(k) clearance on 2020-11-18 under approval number K201382. 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 prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2020-11-18. It is manufactured by De Gotzen S.R.L.. The 510(k) number is K201382.

When was X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) approved by the FDA?

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) received FDA 510(k) clearance on 2020-11-18, under approval number K201382.

What company makes X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is manufactured by De Gotzen S.R.L..

What is the FDA product code for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

The FDA product code for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is OAS.

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Related PubMed Literature

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Other Devices by De Gotzen S.R.L.

K160166X-MIND trium 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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