AGFA

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1065979	3002645723	Agfa US Corporation	1	Y	2026-01-01	1658 Bushy Park Rd GOOSE CREEK SC US 29445
2249582	1000322596	AGFA HEALTHCARE CORP.	1	Y	2026-01-01	580 GOTHAM PARKWAY CARLSTADT NJ US 07072
9613152	3003772616	AGFA-GEVAERT HEALTHCARE GMBH	1	N	2026-01-01	MAX PLANCK STRASSE 1 PEISSENBERG Bavaria DE D82380
9616389	3009471886	AGFA HEALTHCARE N.V.	1	N	2026-01-01	SEPTESTRAAT 27 MORTSEL Antwerpen BE B 2640
3001556265	3001556265	AGFA N.V.	1	N	2026-01-01	Septestraat 27 Mortsel Antwerpen BE B-2640
3002809633	3002809633	Agfa Gevaert N.V.	1	N	2026-01-01	27 Septestraat Mortsel Antwerpen BE B 2640
3009238175	3009238175	Agfa HealthCare	1	N	2026-01-01	Moutstraat 100 Gent West-Vlaanderen BE B-9000
3014527924	1000322596	Agfa US Corporation	1	Y	2026-01-01	580 GOTHAM PARKWAY Carlstadt NJ US 07072
9613151	3003772619	AGFA-GEVAERT HEALTHCARE GMBH	1	N	2020-04-25	BURGERMEISTER-GOTZ STRASSE 10 SCHROBENHAUSEN Bayern DE D86429
3006559622	3006559622	Agfa Material Corporation	1	N	2020-04-25	1658 Bushy Park Rd Goose Creek SC US 29445

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 GUDID	Product	Phone	Email
05414904208168	NX 3.0 - V3.0	+1(877)777-2432	salesinfo@agfa.com
05414904225066	Mamoray HDR-C Plus - MAMORAY HDR-C PLUS 18x24	+1(877)777-2432	salesinfo@agfa.com

agfa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
221667	1593322576	K981280	CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS	IXW	1998-04-30
223634	1593322576	K981280	CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS	IXW	1998-04-30
221667	1734851922	K790273	MAMMOGRAPHY SYSTEM AND CASSETTE	IZH	1979-03-21
223630	1734851922	K790273	MAMMOGRAPHY SYSTEM AND CASSETTE	IZH	1979-03-21
223634	2067279125	K213469	VALORY	MQB	2021-11-18
221667	2067279125	K213469	VALORY	MQB	2021-11-18
221667	1063796869	K212145	DR 800 with DSA, DR 800	JAA	2021-08-31
221667	1250877458	K211790	DX-D Imaging Package with XD Detectors	MQB	2021-07-30
223634	1178737455	K193262	DR 600 with Tomosynthesis	IZF	2020-03-09
221667	1178737455	K193262	DR 600 with Tomosynthesis	IZF	2020-03-09
221667	1290740083	K191884	DR 100s	IZL	2019-08-09
221667	1377023174	K183275	DR 800 with Tomosynthesis	IZF	2019-02-01
221667	1134788960	K180589	DR 800 with MUSICA Dynamic	JAA	2018-04-05
221667	1072814145	K172784	DX-D Imaging Package	MQB	2017-10-13
15263	1830867384	K170434	Enterprise Imaging XERO Viewer 8.1	LLZ	2017-07-03
221667	1184246591	K161368	DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)	MQB	2016-09-22
223634	1184246591	K161368	DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)	MQB	2016-09-22
15263	1549426438	K161061	IMPAX Volume Viewing 4.0	LLZ	2016-06-22
221667	1235645840	K152639	DR 600	MQB	2015-12-11
223634	1235645840	K152639	DR 600	MQB	2015-12-11
15263	1279245399	K143397	ICIS View	LLZ	2015-06-01
130381	1169242868	K142316	IMPAX Agility	LLZ	2015-01-06
15263	1169242868	K142316	IMPAX Agility	LLZ	2015-01-06
221667	1557062292	K142184	DX-D IMAGING PACKAGE	MQB	2014-10-16
221667	1936524713	K141602	DX-D IMAGING PACKAGE	MQB	2014-09-12
221667	1937524179	K141192	DR 400	MQB	2014-06-06
223634	1937524179	K141192	DR 400	MQB	2014-06-06
15263	1763526266	K133135	IMPAX VOLUME VIEWING 3.0	LLZ	2014-03-07
221667	1431410133	K131408	CR 12-X DIGITIZER	MQB	2013-08-29
223634	1431410133	K131408	CR 12-X DIGITIZER	MQB	2013-08-29
223630	1431410133	K131408	CR 12-X DIGITIZER	MQB	2013-08-29
221667	1585562458	K122736	DX-D IMAGING PACKAGE	MQB	2013-03-11
221667	1190514005	K121948	CR 10-X DIGITIZER	MQB	2012-07-20
223630	1190514005	K121948	CR 10-X DIGITIZER	MQB	2012-07-20
223634	1190514005	K121948	CR 10-X DIGITIZER	MQB	2012-07-20
221667	1143622358	K121095	DX-D IMAGING PACKAGE	MQB	2012-08-16
221667	1664837492	K112670	DX-D 600	KPR	2011-10-27
130381	1731412720	K111945	IMPAX NEXT GENERATION	LLZ	2011-08-05
15263	1731412720	K111945	IMPAX NEXT GENERATION	LLZ	2011-08-05
15263	1671274890	K111638	IMPAX VOLUME VIEWING	LLZ	2011-06-24
223634	1979528213	K111324	CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER	MUE	2011-12-22
223630	1979528213	K111324	CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER	MUE	2011-12-22
221667	1979528213	K111324	CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER	MUE	2011-12-22
221667	1804893013	K103597	DX-D 100	IZL	2011-01-03
221667	1292770826	K103050	DX-D 300	KPR	2010-10-29
221667	1490901296	K092669	DX-D IMAGING PACKAGE	MQB	2009-11-06
223634	1386037275	K092238	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS	MQB	2009-08-11
223630	1386037275	K092238	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS	MQB	2009-08-11
221667	1386037275	K092238	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS	MQB	2009-08-11
223634	1545995736	K090672	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS	MQB	2009-05-18
221667	1545995736	K090672	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS	MQB	2009-05-18
15263	1237565415	K081976	IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION	LLZ	2008-07-28
15263	1205396545	K080013	REGISTRATION AND FUSION	LLZ	2008-01-17
221667	1576573270	K073271	ORTHOGON	LLZ	2007-12-05
223634	1952747251	K072680	DRYSTAR AXYS, MODEL EYZ4E	LMC	2007-10-25
221667	1952747251	K072680	DRYSTAR AXYS, MODEL EYZ4E	LMC	2007-10-25
15263	2072429460	K071972	ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS	LLZ	2007-07-30
221667	1072096117	K071297	IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)	LLZ	2007-06-22
223634	1731460508	K071162	AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS	MQB	2007-05-08
221667	1731460508	K071162	AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS	MQB	2007-05-08
221667	1277116000	K062742	CR 85-X	MQB	2006-10-13
223630	1277116000	K062742	CR 85-X	MQB	2006-10-13
223634	1277116000	K062742	CR 85-X	MQB	2006-10-13
221667	1200589065	K062223	AGFA MODEL CR30-X	MQB	2006-09-01
223634	1200589065	K062223	AGFA MODEL CR30-X	MQB	2006-09-01
223630	1200589065	K062223	AGFA MODEL CR30-X	MQB	2006-09-01
223634	1691527754	K053634	COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION	MQB	2006-01-17
221667	1691527754	K053634	COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION	MQB	2006-01-17
15263	1631768721	K050858	ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM	DPS	2005-06-29
15263	1654733130	K050751	IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X	LLZ	2005-04-21
15263	1571911499	K050228	AGFA HEARTLAB CARDIOVASCULAR	LLZ	2005-02-18
223634	1112201508	K041701	AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM	MQB	2004-07-22
221667	1112201508	K041701	AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM	MQB	2004-07-22
223630	1112201508	K041701	AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM	MQB	2004-07-22
15263	1230610983	K040555	IMPAX CLIENT EMBRACE	LLZ	2004-05-26
15263	1649724293	K040344	IMPAX OT3000 ORTHOPEDIC WORKSTATION	LLZ	2004-05-12
223634	1563925546	K032635	DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300	LMC	2003-09-24
221667	1563925546	K032635	DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300	LMC	2003-09-24
221667	1234027488	K023287	DRYSTAR 5500	LMC	2002-10-22
223634	1234027488	K023287	DRYSTAR 5500	LMC	2002-10-22
223630	1392634104	K023020	AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE	IXA	2002-09-26
221667	1392634104	K023020	AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE	IXA	2002-09-26
15263	1083636073	K022292	IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO	LLZ	2002-09-12
15263	2026132650	K022292	IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO	LLZ	2002-09-12
223630	1727663278	K021542	ADC DENTAL	MUH	2002-08-06
221667	1727663278	K021542	ADC DENTAL	MUH	2002-08-06
223634	1727663278	K021542	ADC DENTAL	MUH	2002-08-06
221667	1114716778	K012546	OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM	KPR	2001-11-02
221667	1064681102
223630	1064681102
72486	1246386921
223630	1648129066
221667	1231077988
72584	1246386921
223634	1406809411
221667	1406809411
221667	1648129066
221667	1705059940
223634	1705059940
221667	1762358574

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
MQB	39	2021-11-18
LLZ	20	2017-07-03
LMC	6	2007-10-25
IZF	3	2020-03-09
MUE	3	2011-12-22
KPR	3	2011-10-27
MUH	3	2002-08-06
JAA	2	2021-08-31
IZL	2	2019-08-09
IXA	2	2002-09-26
IXW	2	1998-04-30
IZH	2	1979-03-21
DPS	1	2005-06-29