Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8021091

FEI Number

3002808461

Entity Name

VILLA SISTEMI MEDICALI S.P.A.

City/State/Country

BUCCINASCO Milano, IT

Establishment Address

VIA DELLE AZALEE 3, BUCCINASCO Milano 20090, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Villa Sistemi Medicali S.p.A. (Owner Number: 9027610)

Owner / Operator Contact Address

via delle Azalee 3, Buccinasco, IT-MI 20090, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K050190

PMA Number

N/A

All Registered Proprietary Names

DRF 4343 FL DRF 4343 DRF 4343-TS DRF 4343-LT System DT Apollo EZ Apollo EZ DRF Apollo Apollo DRF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2008-11-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2008-11-22
IXL	Device, Spot-Film	Radiology	Class 2	892.1670	2007-11-30
KPW	Device, Beam Limiting, X-Ray, Diagnostic	Radiology	Class 2	892.1610	2007-11-30
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2007-11-30

Official Correspondent

No official correspondent registered.

US Agent Details

George Bell Business: DEL Medical, Inc Email: gbell@delmedical.com Phone: (847) 2887029

Related Public Records

Same Entity

Villa Sistemi Medicali S.p.A.

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
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K863853	Superior Medical Products	EAZY COVERS	1987-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

Similar Registrations

Registration Number	Establishment Name	Location
3016256852	KA IMAGING INC.	Waterloo Ontario, CA
3011825597	FAIR MEDICAL CO.,LTD	Kashiwa Chiba, JP
3038614464	Canon.Inc	OHTA-KU Tokyo, JP
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021091. Last updated year: 2026. Please use registration number 8021091 when referencing this establishment in official correspondence.