Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003528079

FEI Number

3003528079

Entity Name

XLINE SRL

City/State/Country

ASSAGO Milano, IT

Establishment Address

VIA GALILEI 18, ASSAGO Milano 20057, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XLINE S.r.l. (Owner Number: 10061120)

Owner / Operator Contact Address

Via Galilei 18, Assago, IT-MI 20057, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161131

PMA Number

N/A

All Registered Proprietary Names

IntraOs 70 IntraOs DG Vario DG Stellaris 3D Ceph Stellaris 2D Stellaris 2D Ceph Stellaris 3D PantOs 16 xp Ceph PantOs DG xp PantOs 16 xp StarX-1 StarX PRO-1 StarX-2 StarX PRO-2 FONA ART Plus FONA XPan DG FONA XPan DG Plus FONA ART Plus C

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	2019-08-23
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2022-03-07
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2019-08-23
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2019-08-23
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-08-23
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2021-08-31
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2019-08-23

Official Correspondent

Luigi Germano

US Agent Details

Nilo Gomez Email: nilogomez1@gmail.com Phone: (832) 6234072

Related Public Records

Same Entity

XLINE 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
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04

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-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

Registration Number	Establishment Name	Location
3005581016	GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD	GUILIN CITY Guangxi, CN
3007933232	DIGIMED CO., LTD	Seoul, KR
3002994636	DE GOTZEN S.R.L.	FAGNANO OLONA Varese, 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 3003528079. Last updated year: 2026. Please use registration number 3003528079 when referencing this establishment in official correspondence.