Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003314115

FEI Number

3003314115

Entity Name

NICAL SPA

City/State/Country

MILAN (MI) Lombardy, IT

Establishment Address

43 VIA SOFFREDINI, MILAN (MI) Lombardy 20126, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NICAL SPA (Owner Number: 9019546)

Owner / Operator Contact Address

43 VIA SOFFREDINI, --, MILAN (MI), IT-NOTA 20126, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143703

PMA Number

N/A

All Registered Proprietary Names

NDR+AND DIVA-D SecurScan 500 GBS Technologies NICAL NFP Digital detector NICAL SMART MICRO, NSM1001AA,NPR1000AA, NPR1000VE.

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	2006-11-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2006-11-03
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2015-04-03

Official Correspondent

No official correspondent registered.

US Agent Details

GERALD SILVERMAN Business: GBS TECHNOLOGIES Email: silverj7@optonline.net Phone: (914) 2757679

Related Public Records

Same Entity

NICAL SPA

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
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17

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-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
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 3003314115. Last updated year: 2026. Please use registration number 3003314115 when referencing this establishment in official correspondence.