FDA.reportPublic FDA data

AGFA N.V.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30015562653001556265AGFA N.V.1N2026-01-01Septestraat 27 Mortsel Antwerpen BE B-2640

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2216671593322576K981280CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMSIXW1998-04-30
2216671734851922K790273MAMMOGRAPHY SYSTEM AND CASSETTEIZH1979-03-21
2216672067279125K213469VALORYMQB2021-11-18
2216671063796869K212145DR 800 with DSA, DR 800JAA2021-08-31
2216671250877458K211790DX-D Imaging Package with XD DetectorsMQB2021-07-30
2216671178737455K193262DR 600 with TomosynthesisIZF2020-03-09
2216671290740083K191884DR 100sIZL2019-08-09
2216671377023174K183275DR 800 with TomosynthesisIZF2019-02-01
2216671134788960K180589DR 800 with MUSICA DynamicJAA2018-04-05
2216671072814145K172784DX-D Imaging PackageMQB2017-10-13
2216671184246591K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)MQB2016-09-22
2216671235645840K152639DR 600MQB2015-12-11
2216671557062292K142184DX-D IMAGING PACKAGEMQB2014-10-16
2216671936524713K141602DX-D IMAGING PACKAGEMQB2014-09-12
2216671937524179K141192DR 400MQB2014-06-06
2216671431410133K131408CR 12-X DIGITIZERMQB2013-08-29
2216671585562458K122736DX-D IMAGING PACKAGEMQB2013-03-11
2216671190514005K121948CR 10-X DIGITIZERMQB2012-07-20
2216671143622358K121095DX-D IMAGING PACKAGEMQB2012-08-16
2216671664837492K112670DX-D 600KPR2011-10-27
2216671979528213K111324CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZERMUE2011-12-22
2216671804893013K103597DX-D 100IZL2011-01-03
2216671292770826K103050DX-D 300KPR2010-10-29
2216671490901296K092669DX-D IMAGING PACKAGEMQB2009-11-06
2216671386037275K092238AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERSMQB2009-08-11
2216671545995736K090672AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONSMQB2009-05-18
2216671576573270K073271ORTHOGONLLZ2007-12-05
2216671952747251K072680DRYSTAR AXYS, MODEL EYZ4ELMC2007-10-25
2216671072096117K071297IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)LLZ2007-06-22
2216671731460508K071162AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONSMQB2007-05-08
2216671277116000K062742CR 85-XMQB2006-10-13
2216671200589065K062223AGFA MODEL CR30-XMQB2006-09-01
2216671691527754K053634COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATIONMQB2006-01-17
2216671112201508K041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEMMQB2004-07-22
2216671563925546K032635DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300LMC2003-09-24
2216671234027488K023287DRYSTAR 5500LMC2002-10-22
2216671392634104K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTEIXA2002-09-26
2216671727663278K021542ADC DENTALMUH2002-08-06
2216671114716778K012546OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEMKPR2001-11-02
2216671064681102
2216671231077988
2216671406809411
2216671648129066
2216671705059940
2216671762358574

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB202021-11-18
KPR32011-10-27
LMC32007-10-25
JAA22021-08-31
IZF22020-03-09
IZL22019-08-09
LLZ22007-12-05
MUE12011-12-22
IXA12002-09-26
MUH12002-08-06
IXW11998-04-30
IZH11979-03-21

PMN#