Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680497

FEI Number

3008794078

Entity Name

AGFA HEALTHCARE INC.

City/State/Country

WATERLOO Ontario, CA

Establishment Address

375 Hagey Boulevard, WATERLOO Ontario N2L 6R5, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AGFA HEALTHCARE N.V. (Owner Number: 9011611)

Owner / Operator Contact Address

375 Hagey Blvd, Waterloo, CA-ON N2L 6R5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040344

PMA Number

N/A

All Registered Proprietary Names

Enterprise Imaging XERO Viewer Impax Orthopaedic Workstation OT 3000 MA3000 IMPAX Impax for Breast Imaging IMPAX Mammography Workstation MA3000 Impax for Breast Imaging Enterprise Imaging Desktops Enterprise Imaging Desktops IMPAX Diagnostic Workstation IMPAX Quality Control Workstation IMPAX Clinical Workstation IMPAX Workstation IMPAX PET & SPECT Viewing IMPAX Registration & Fusion Enterprise Imaging XERO Viewer 8.1 XERO Viewer Enterprise Imaging IMPAX Orthopaedic Workstation Ortho Tool Kit Impax Orthopaedic Workstation OT 3000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-10-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-01-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-01-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-05-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2015-01-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-08-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2007-11-19
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-05-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2017-07-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-01-16
HWT	Template	Orthopedic	Class 1	888.4800	2008-01-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

Joanne Hassell Email: joanne.hassell@agfa.com Phone: (551) 5560553

Related Public Records

Same Entity

AGFA HEALTHCARE N.V.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009238185	Agfa HealthCare GmbH	Vienna Wien, AT
3009238175	Agfa HealthCare	Gent West-Vlaanderen, BE
9616389	AGFA HEALTHCARE N.V.	MORTSEL Antwerpen, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

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)

Similar Registrations

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3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3036758981	TAEYOUNG SOFT	Gwacheon-si Gyeonggi, KR
3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3030088963	REBRAIN	PESSAC Gironde, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680497. Last updated year: 2026. Please use registration number 9680497 when referencing this establishment in official correspondence.