Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002994636

FEI Number

3002994636

Entity Name

DE GOTZEN S.R.L.

City/State/Country

FAGNANO OLONA Varese, IT

Establishment Address

STRADA PROVINCIALE BUSTO-CASSANO 3, FAGNANO OLONA Varese 21054, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DE GOTZEN S.R.L. (Owner Number: 9012111)

Owner / Operator Contact Address

STRADA PROVINCIALE BUSTO-CASSANO 3, FAGNANO OLONA, IT-VA 21054, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173041

PMA Number

N/A

All Registered Proprietary Names

x-mind dc Acteon Imaging Suite X-MIND unity X-MIND prime 3D X-MIND optima 3D AIS 3D app RealGUIDE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2024-01-10
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-02-26
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2014-06-04
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2020-12-09
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2020-12-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-09-02

Official Correspondent

No official correspondent registered.

US Agent Details

Noelle Zuccarello Business: Acteon, Inc Email: noelle.zuccarello@acteongroup.com Phone: (800) 2896367

Related Public Records

Same Entity

DE GOTZEN S.R.L.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K991310	Villa Sistemi Medicali S.P.A.	EXPLOR-X 70	1999-06-18
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2015	Gendex Corp	2	eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eDC; and Assy, Articulated Arm & Tubehead, 765DC Product Usage: intraoral x-ray
Z-0016-2017	Panoramic Rental Corp.	2	Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2

Similar Registrations

Registration Number	Establishment Name	Location
3005581016	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD	GUILIN CITY Guangxi, CN
3007933232	DIGIMED CO., LTD	Seoul, KR
3003528079	XLINE SRL	ASSAGO Milano, IT
3008770655	BEYES DENTAL INC	Toronto Ontario, CA
3008252267	Ningbo Runyes Medical Instrument Co., Ltd.	Ningbo Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002994636. Last updated year: 2026. Please use registration number 3002994636 when referencing this establishment in official correspondence.