AGFA

Address:Septestraat 27,Mortsel Antwerpen,BE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Solid state x-ray imager (flat panel/digital imager) (MQB) (7) Film, radiographic (IWZ) (3)

Premarket Exempt

No Yes

Clear

CR MD4.0 GENERAL PLATE - 05414904027509 Catalog Number : EJYYC

Device Description : CR MD4.0 GENERAL PLATE 15X30CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904027516 Catalog Number : EJYZE

Device Description : CR MD4.0 GENERAL PLATE 8X10I.

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR HD5.0 GENERAL SR DETECTOR - 05414904027905 Catalog Number : E4T84

Device Description : CR HD5.0 GENERAL SR DETECTOR 35CM X 43CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0T PLATE - 05414904027943 Catalog Number : E4UWL

Device Description : CR MD4.0T PLATE 35CM X 43CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0T PLATE - 05414904027967 Catalog Number : E4UZR

Device Description : CR MD4.0T PLATE 24CM X 30CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0T PLATE - 05414904027998 Catalog Number : E4VCK

Device Description : CR MD4.0T PLATE 18CM X 24CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0T PLATE - 05414904028001 Catalog Number : E4VEO

Device Description : CR MD4.0T PLATE 15CM X 30CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

M Plus - Half Blue - 05414904028438 Catalog Number : 3XA2A

Device Class :

Duns Number: 374444883

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : Yes

Device Count : 100

M Plus - Half Blue - 05414904028575 Catalog Number : 3XA3C

Device Class :

Duns Number: 374444883

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : Yes

Device Count : 100

M Plus - Half Blue - 05414904028599 Catalog Number : 3XA5G

Device Class :

Duns Number: 374444883

Premarket Exempt : Yes

Product Code : IWZ

Prescription Use : Yes

Device Count : 100

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