Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021915828

FEI Number

3021915828

Entity Name

NICo-Lab B.V.

City/State/Country

Amsterdam Noord-Holland, NL

Establishment Address

Paasheuvelweg 25, Amsterdam Noord-Holland 1105 BP, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NICo-lab B.V. (Owner Number: 10084560)

Owner / Operator Contact Address

Paasheuvelweg 25, Amsterdam, NL-NH 1105 BP, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200873

PMA Number

N/A

All Registered Proprietary Names

StrokeViewer LVO Triaging StrokeViewer Perfusion StrokeViewer LVO Triaging

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2022-03-07
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-12-19
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2022-03-07

Official Correspondent

Ralf-Peter Herber

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

NICo-lab B.V.

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
K220709	Aidoc Medical , Ltd.	BriefCase	2022-10-07
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3023702863	Harrison-AI Medical Pty Ltd	Sydney New South Wales, AU
3004977335	Siemens Healthineers AG	FORCHHEIM Bavaria, DE
3017840913	QURE.AI TECHNOLOGIES PRIVATE LIMITED	Mumbai Maharashtra, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021915828. Last updated year: 2026. Please use registration number 3021915828 when referencing this establishment in official correspondence.