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
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
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
05414904027158	CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 10X12I.	+1(877)777-2432	salesinfo@agfa.com
05414904027202	CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 35X43CM	+1(877)777-2432	salesinfo@agfa.com
05414904027219	CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 35X35CM	+1(877)777-2432	salesinfo@agfa.com
05414904027226	CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 24X30CM	+1(877)777-2432	salesinfo@agfa.com
05414904027363	CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 18X24CM	+1(877)777-2432	salesinfo@agfa.com
05414904027509	CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 15X30CM	+1(877)777-2432	salesinfo@agfa.com
05414904027516	CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 8X10I.	+1(877)777-2432	salesinfo@agfa.com
05414904027943	CR MD4.0T PLATE - CR MD4.0T PLATE 35CM X 43CM	+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
223630	1734851922	K790273	MAMMOGRAPHY SYSTEM AND CASSETTE	IZH	1979-03-21
221667	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
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
223634	1235645840	K152639	DR 600	MQB	2015-12-11
221667	1235645840	K152639	DR 600	MQB	2015-12-11
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
223630	1431410133	K131408	CR 12-X DIGITIZER	MQB	2013-08-29
223634	1431410133	K131408	CR 12-X DIGITIZER	MQB	2013-08-29
221667	1431410133	K131408	CR 12-X DIGITIZER	MQB	2013-08-29
221667	1585562458	K122736	DX-D IMAGING PACKAGE	MQB	2013-03-11
223630	1190514005	K121948	CR 10-X DIGITIZER	MQB	2012-07-20
223634	1190514005	K121948	CR 10-X DIGITIZER	MQB	2012-07-20
221667	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
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
223634	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
221667	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
223634	1386037275	K092238	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS	MQB	2009-08-11
221667	1545995736	K090672	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS	MQB	2009-05-18
223634	1545995736	K090672	AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS	MQB	2009-05-18
221667	1576573270	K073271	ORTHOGON	LLZ	2007-12-05
221667	1952747251	K072680	DRYSTAR AXYS, MODEL EYZ4E	LMC	2007-10-25
223634	1952747251	K072680	DRYSTAR AXYS, MODEL EYZ4E	LMC	2007-10-25
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
223630	1277116000	K062742	CR 85-X	MQB	2006-10-13
221667	1277116000	K062742	CR 85-X	MQB	2006-10-13
223634	1277116000	K062742	CR 85-X	MQB	2006-10-13
223630	1200589065	K062223	AGFA MODEL CR30-X	MQB	2006-09-01
223634	1200589065	K062223	AGFA MODEL CR30-X	MQB	2006-09-01
221667	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
223630	1112201508	K041701	AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM	MQB	2004-07-22
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
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
223634	1234027488	K023287	DRYSTAR 5500	LMC	2002-10-22
221667	1234027488	K023287	DRYSTAR 5500	LMC	2002-10-22
221667	1392634104	K023020	AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE	IXA	2002-09-26
223630	1392634104	K023020	AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE	IXA	2002-09-26
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
223630	1064681102
221667	1064681102
72486	1246386921
223630	1648129066
221667	1231077988
72584	1246386921
221667	1406809411
223634	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
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
LLZ	2	2007-12-05
IXA	2	2002-09-26
IXW	2	1998-04-30
IZH	2	1979-03-21

PMN#

AGFA HealthCare Enterprise Imaging
2025-10-15
Agfa Healthcare N.V.
VALORY
2021-11-18
Agfa N.V.
DR 800 with DSA, DR 800
2021-08-31
Agfa N.V.
DX-D Imaging Package With XD Detectors
2021-07-30
Agfa N.V.
DR 600 With Tomosynthesis
2020-03-09
Agfa N.V.
DR 100s
2019-08-09
Agfa N.V.
DR 800 With Tomosynthesis
2019-02-01
Agfa N.V.
DR 800 With MUSICA Dynamic
2018-04-05
Agfa HealthCare N.V.
DX-D Imaging Package
2017-10-13
Agfa HealthCare N.V.
Enterprise Imaging XERO Viewer 8.1
2017-07-03
Agfa HealthCare N.V.
DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)
2016-09-22
Agfa HealthCare N.V.
IMPAX Volume Viewing 4.0
2016-06-22
AGFA HEALTHCARE N.V.
DR 600
2015-12-11
AGFA HEALTHCARE N.V.
ICIS View
2015-06-01
Agfa HealthCare N.V.
IMPAX Agility
2015-01-06
AGFA HEALTHCARE N.V.
DX-D IMAGING PACKAGE
2014-10-16
AGFA HEALTHCARE N.V.
DX-D IMAGING PACKAGE
2014-09-12
AGFA HEALTHCARE N.V.
DR 400
2014-06-06
AGFA HEALTHCARE N.V.
IMPAX VOLUME VIEWING 3.0
2014-03-07
AGFA HEALTHCARE N.V.
SKINTELL
2014-03-03
AGFA HEALTHCARE N.V.
CR 12-X DIGITIZER
2013-08-29
AGFA HEALTHCARE N.V.
DX-D IMAGING PACKAGE
2013-03-11
AGFA HEALTHCARE N.V.
DX-D IMAGING PACKAGE
2012-08-16
AGFA HEALTHCARE N.V.
CR 10-X DIGITIZER
2012-07-20
AGFA HEALTHCARE N.V.
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
2011-12-22
AGFA HEALTHCARE N.V.
DX-D 600
2011-10-27
AGFA HEALTHCARE N.V.
IMPAX NEXT GENERATION
2011-08-05
AGFA HEALTHCARE N.V.
IMPAX VOLUME VIEWING
2011-06-24
AGFA HEALTHCARE N.V.
DX-D 100
2011-01-03
AGFA HEALTHCARE N.V.
DX-D 300
2010-10-29
AGFA HEALTHCARE N.V.
DX-D IMAGING PACKAGE
2009-11-06
AGFA HEALTHCARE N.V.
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS
2009-08-11
AGFA HEALTHCARE N.V.
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS
2009-05-18
AGFA HEALTHCARE N.V.
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
2008-07-28
AGFA HEALTHCARE CORPORATION
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
2008-07-25
AGFA HEALTHCARE CORPORATION
REGISTRATION AND FUSION
2008-01-17
AGFA HEALTHCARE CORPORATION
ORTHOGON
2007-12-05
AGFA HEALTHCARE CORPORATION
DRYSTAR AXYS, MODEL EYZ4E
2007-10-25
AGFA HEALTHCARE CORPORATION
ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS
2007-07-30
AGFA HEALTHCARE CORP.
IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
2007-06-22
AGFA HEALTHCARE CORP.

67 records. Showing 1-40. Next

GUDID#

CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 10X12I.
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 35X43CM
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 35X35CM
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 24X30CM
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 18X24CM
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 15X30CM
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 8X10I.
AGFA
2016-09-01
CR MD4.0T PLATE - CR MD4.0T PLATE 35CM X 43CM
AGFA
2016-09-01
CR MD4.0T PLATE - CR MD4.0T PLATE 24CM X 30CM
AGFA
2016-09-01
CR MD4.0T PLATE - CR MD4.0T PLATE 18CM X 24CM
AGFA
2016-09-01
CR MD4.0T PLATE - CR MD4.0T PLATE 15CM X 30CM
AGFA
2016-09-01
CR MD4.0R GENERAL PLATE - CR MD4.0R GENERAL PLATE 15CM X 30CM
AGFA
2016-09-01
CR MD4.0R GENERAL PLATE - CR MD4.0R GENERAL PLATE 18CM X 24CM
AGFA
2016-09-01
CR MD4.0R GENERAL PLATE - CR MD4.0R GENERAL PLATE 24CM X 30CM
AGFA
2016-09-01
CR MD4.0R GENERAL PLATE - CR MD4.0R GENERAL PLATE 35CM X 35CM
AGFA
2016-09-01
CR MD4.0R GENERAL PLATE - CR MD4.0R GENERAL PLATE 35CM X 43CM
AGFA
2016-09-01
CR MD4.0R GENERAL SR PLATE - CR MD4.0R GENERALSR PLATE 35CM X 35CM
AGFA
2016-09-01
CR MD4.0R GENERAL SR PLATE - CR MD4.0R GENERALSR PLATE 35CM X 43CM
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 14X51I.
AGFA
2016-09-01
CR MD1.0 GENERAL PLATE - CR MD1.0 GENERAL PLATE 35X43
AGFA
2016-09-01
CR MD4.0T PLATE - CR MD4.0T PLATE 35CM X 35CM
AGFA
2016-09-01
CR MD1.0 GENERAL PLATE - CR MD1.0 GENERAL PLATE 24X30
AGFA
2016-09-01
CR MD1.0 GENERAL PLATE - CR MD1.0 GENERAL PLATE 18X24
AGFA
2016-09-01
CR MD1.0 GENERAL PLATE - CR MD1.0 GENERAL PLATE 15X30
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 17X17 INCH
AGFA
2016-09-01
CR MD4.0 GENERAL PLATE - CR MD4.0 GENERAL PLATE 14X34 INCH
AGFA
2016-09-01
CR MD1.0F GENERAL PLATE - CR MD1.0F GEN.PL. 15X30 INS.35X43CM
AGFA
2016-09-01
NX 4.0 - V4.0
AGFA
2023-07-18
DX-M - DX-M DIGITIZER
AGFA
2016-09-01
CR 10-X - CR 10-X DIGITIZER
AGFA
2016-09-01
CR READER - 5151/110
AGFA
2016-09-01
CR 12-X - CR 12-X DIGITIZER
AGFA
2016-09-01
CR ADVANCED READER - 5151/210
AGFA
2016-09-01
CR 15-X - CR 15-X DIGITIZER
AGFA
2016-09-01
CR MULTIFORMAT READER - 5151/310
AGFA
2016-09-01
CR HD5.0 GENERAL DETECTOR - CR HD5.0 GENERAL DETECTOR 15X30
AGFA
2016-09-01
CR HD5.0 GENERAL DETECTOR - CR HD5.0 GENERAL DETECTOR 18X24
AGFA
2016-09-01
CR HD5.0 GENERAL DETECTOR - CR HD5.0 GENERAL DETECTOR 24X30CM
AGFA
2016-09-01
CR HD5.0 GENERAL DETECTOR - CR HD5.0 GENERAL DETECTOR 35CM X 43CM
AGFA
2016-09-01
CR MD4.0T GENERAL SET - CR MD4.0T GENERAL SET 35CM X 43CM
AGFA
2016-09-01

200 records. Showing 1-40. Next