De Gotzen S.r.l.

FAGNANO OLONA Varese, IT

DE GOTZEN S.R.L. appears in FDA device records in FAGNANO OLONA Varese, IT. FDA records list 7 510(k) clearances between 2014-05-30 and 2023-12-28, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 7
PMA records: 0
Recall records: 1
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to De Gotzen S.r.l. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

DeGotzenenforcement report, recall

510(k) clearance history

FDA records hold 7 510(k) clearances for De Gotzen S.r.l. between 2014 and 2023. The busiest year on record is 2020, with 3. The most recent is 2023, with 1.

Clearances by year, as a table

510(k) clearance decisions for De Gotzen S.r.l., by decision year
Year	Clearances
2014	1
2016	1
2020	3
2021	1
2023	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K231055	x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)	EHD	Substantially Equivalent	2023-12-28
K203374	X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)	MUH	Substantially Equivalent	2021-02-05
K201382	X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)	OAS	Substantially Equivalent	2020-11-18
K191719	X-MIND Trium	MUH	Substantially Equivalent	2020-02-20
K192165	Acteon Imaging Suite	LLZ	Substantially Equivalent	2020-02-11
K160166	X-MIND trium	OAS	Substantially Equivalent	2016-11-15
K132378	X-MIND UNITY	EHD	Substantially Equivalent	2014-05-30

Registered establishments

FDA registered establishments for De Gotzen S.r.l., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3002994636	3002994636	DE GOTZEN S.R.L.	STRADA PROVINCIALE BUSTO-CASSANO 3, FAGNANO OLONA Varese 21054 IT	2026	EHD LLZ MUH OAS

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1020-2013	DeGotzen XRay unit XGenus Dental X-ray unit.	It was discovered at the WEAC Labs method sample did not meet requirements for labeling and certification	Class II	2012-09-26	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets De Gotzen S.r.l. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain