FDA.reportPublic FDA data

AGFA HEALTHCARE N.V.

Matched from indexed company URL: Agfa HealthCare N.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96163893009471886AGFA HEALTHCARE N.V.1N2026-01-01SEPTESTRAAT 27 MORTSEL Antwerpen BE B 2640

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05400874000703Enterprise Imaging Desktops - Enterprise Imaging Desktops 8.x1-866-599-3868salesinfo@agfa.com
05400874000710Enterprise Imaging XERO Viewer - Enterprise Imaging XERO Viewer 8.x1-866-599-3868salesinfo@agfa.com
05400874001205IMPAX Clinical Applications - IMPAX Volume Viewing and IMPAX PET & SPECT Viewing1-866-599-3868salesinfo@agfa.com
05414904216552IMPAX - IMPAX SW CLIENT V6.7+1(877)777-2432salesinfo@agfa.com
05414904218525Enterprise Imaging Desktops - ENT IMG SW 8.+1(877)777-2432salesinfo@agfa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
152631830867384K170434Enterprise Imaging XERO Viewer 8.1LLZ2017-07-03
152631549426438K161061IMPAX Volume Viewing 4.0LLZ2016-06-22
152631279245399K143397ICIS ViewLLZ2015-06-01
152631169242868K142316IMPAX AgilityLLZ2015-01-06
152631763526266K133135IMPAX VOLUME VIEWING 3.0LLZ2014-03-07
152631731412720K111945IMPAX NEXT GENERATIONLLZ2011-08-05
152631671274890K111638IMPAX VOLUME VIEWINGLLZ2011-06-24
152631237565415K081976IMPAX MA3000 DIAGNOSTIC PACS WORKSTATIONLLZ2008-07-28
152631205396545K080013REGISTRATION AND FUSIONLLZ2008-01-17
152632072429460K071972ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONSLLZ2007-07-30
152631631768721K050858ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEMDPS2005-06-29
152631654733130K050751IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.XLLZ2005-04-21
152631571911499K050228AGFA HEARTLAB CARDIOVASCULARLLZ2005-02-18
152631230610983K040555IMPAX CLIENT EMBRACELLZ2004-05-26
152631649724293K040344IMPAX OT3000 ORTHOPEDIC WORKSTATIONLLZ2004-05-12
152631083636073K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHOLLZ2002-09-12
152632026132650K022292IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHOLLZ2002-09-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ162017-07-03
DPS12005-06-29

PMN#

DR 600

2015-12-11

AGFA HEALTHCARE N.V.

DR 400

2014-06-06

AGFA HEALTHCARE N.V.

GUDID#