FDA.reportPublic FDA data

AGFA-GEVAERT HEALTHCARE GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96131523003772616AGFA-GEVAERT HEALTHCARE GMBH1N2026-01-01MAX PLANCK STRASSE 1 PEISSENBERG Bavaria DE D82380
96131513003772619AGFA-GEVAERT HEALTHCARE GMBH1N2020-04-25BURGERMEISTER-GOTZ STRASSE 10 SCHROBENHAUSEN Bayern DE D86429

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2236341593322576K981280CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMSIXW1998-04-30
2236301734851922K790273MAMMOGRAPHY SYSTEM AND CASSETTEIZH1979-03-21
2236342067279125K213469VALORYMQB2021-11-18
2236341178737455K193262DR 600 with TomosynthesisIZF2020-03-09
2236341184246591K161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)MQB2016-09-22
2236341235645840K152639DR 600MQB2015-12-11
2236341937524179K141192DR 400MQB2014-06-06
2236301431410133K131408CR 12-X DIGITIZERMQB2013-08-29
2236341431410133K131408CR 12-X DIGITIZERMQB2013-08-29
2236301190514005K121948CR 10-X DIGITIZERMQB2012-07-20
2236341190514005K121948CR 10-X DIGITIZERMQB2012-07-20
2236301979528213K111324CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZERMUE2011-12-22
2236341979528213K111324CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZERMUE2011-12-22
2236301386037275K092238AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERSMQB2009-08-11
2236341386037275K092238AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERSMQB2009-08-11
2236341545995736K090672AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONSMQB2009-05-18
2236341952747251K072680DRYSTAR AXYS, MODEL EYZ4ELMC2007-10-25
2236341731460508K071162AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONSMQB2007-05-08
2236301277116000K062742CR 85-XMQB2006-10-13
2236341277116000K062742CR 85-XMQB2006-10-13
2236301200589065K062223AGFA MODEL CR30-XMQB2006-09-01
2236341200589065K062223AGFA MODEL CR30-XMQB2006-09-01
2236341691527754K053634COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATIONMQB2006-01-17
2236301112201508K041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEMMQB2004-07-22
2236341112201508K041701AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEMMQB2004-07-22
2236341563925546K032635DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300LMC2003-09-24
2236341234027488K023287DRYSTAR 5500LMC2002-10-22
2236301392634104K023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTEIXA2002-09-26
2236301727663278K021542ADC DENTALMUH2002-08-06
2236341727663278K021542ADC DENTALMUH2002-08-06
2236301064681102
2236301648129066
2236341406809411
2236341705059940

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MQB192021-11-18
LMC32007-10-25
MUE22011-12-22
MUH22002-08-06
IZF12020-03-09
IXA12002-09-26
IXW11998-04-30
IZH11979-03-21