Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020997

FEI Number

3002807092

Entity Name

GENERAL MEDICAL MERATE S.P.A.

City/State/Country

SERIATE, BERGAMO, IT

Establishment Address

VIA PARTIGIANI, 25, SERIATE, BERGAMO 24068, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GENERAL MEDICAL MERATE S.P.A. (Owner Number: 8020997)

Owner / Operator Contact Address

VIA PARTIGIANI, 25, --, SERIATE, BERGAMO, IT-NOTA 24068, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213081

PMA Number

N/A

All Registered Proprietary Names

CLISIS SYSTEMS, Discovery RF180 Discovery RF180 CLISIS SYSTEMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2018-05-29
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-05-29
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-05-29
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2018-05-29
IZF	System, X-Ray, Tomographic	Radiology	Class 2	892.1740	2021-12-15
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2021-12-15
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2021-12-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-12-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2021-12-15

Official Correspondent

Alessandro Mozzi

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

GENERAL MEDICAL MERATE 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
3003768277	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3010949642	GE HEALTHCARE (TIANJIN) COMPANY LIMITED	Tianjin, CN
3011491794	ECOTRON Co., Ltd.	Seoul, KR
3013836619	Baxter Medical Systems (Suzhou) Co. Ltd	Taicang City Jiangsu, CN
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020997. Last updated year: 2026. Please use registration number 8020997 when referencing this establishment in official correspondence.