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De Gotzen S.R.L.

FDA Regulatory Profile

De Gotzen S.R.L. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 21, 2017 · NAI
Latest 510(k)
Nov 18, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 21, 2017Olgiate Olona, ItalyDevicesNo Action Indicated (NAI)3002994636

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)Nov 18, 2020
K191719X-MIND TriumFeb 20, 2020
K192165Acteon Imaging SuiteFeb 11, 2020
K160166X-MIND triumNov 15, 2016
K132378X-MIND UNITYMay 30, 2014

FDA data resources