Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000181154

FEI Number

1000181154

Entity Name

BARCO S.R.L.

City/State/Country

Saronno Varese, IT

Establishment Address

Via Saul Banfi, 1, Saronno Varese 21047, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BARCO NV (Owner Number: 9031117)

Owner / Operator Contact Address

Beneluxpark 21, Kortrijk, BE-VWV 8500, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MDPC-8127 Coronis OneLook MDMC-32133 MDNC-8132 Nio Color 8MP MDRC-1219 MDRC-1219 HB MDRC-2222 MDRC-2324 MDRC-2321 MDRC-2422 MDRC-2424 MDRC-1419 MDRC-8132 MDRC-8127 MDRC-2421 MDNC-12130 Nio Fusion 12MP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2021-04-23
PZZ	Digital Pathology Display	Pathology	Class 2	864.3700	2021-04-23
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-09-23
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-12-12
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2001-08-13
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2020-11-19

Official Correspondent

No official correspondent registered.

US Agent Details

Roxana Allen Business: Barco Inc. Email: roxana.allen@barco.com Phone: (678) 2008674

Related Public Records

Same Entity

BARCO NV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004578804	Barco, Inc	DULUTH, GA, US
3024689474	Barco Inc Portland	Portland, OR, US
3024137003	Barco (Suzhou) Healthcare Technology Co., Ltd.	Suzhou Jiangsu, CN
9613188	BARCO N.V.	KORTRIJK West-Vlaanderen, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1	2025-03-06
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15

Similar Registrations

Registration Number	Establishment Name	Location
3012563754	Philips Medical Systems Nederland B.V.	Best Noord-Brabant, NL
3008491142	FUJIFILM Healthcare Americas Corporation	Lexington, MA, US
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
9614683	HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION	HAMAMATSU CITY Shizuoka, JP
3017125738	PAIGE.AI, INC	New York, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000181154. Last updated year: 2026. Please use registration number 1000181154 when referencing this establishment in official correspondence.