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) (10)

Premarket Exempt

No Yes

Clear

CR MD4.0R GENERAL SET - 05414904026601 Catalog Number : E49YE

Device Description : CR MD4.0R GENERAL SET. 35CM X 43CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0R GENERAL SET - 05414904026618 Catalog Number : E49ZG

Device Description : CR MD4.0R GENERAL SET.35CM X 35CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0R GENERAL SET - 05414904026786 Catalog Number : E492L

Device Description : CR MD4.0R GENERAL SET 24CM X 30CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0R GENERAL SET - 05414904026793 Catalog Number : E493N

Device Description : CR MD4.0R GENERAL SET. 18CM X 24CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0R GENERAL SET - 05414904026809 Catalog Number : E494P

Device Description : CR MD4.0R GENERAL SET 15CM X 30CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904027158 Catalog Number : EJY1G

Device Description : CR MD4.0 GENERAL PLATE 10X12I.

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904027202 Catalog Number : EJYU3

Device Description : CR MD4.0 GENERAL PLATE 35X43CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904027219 Catalog Number : EJYV5

Device Description : CR MD4.0 GENERAL PLATE 35X35CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904027226 Catalog Number : EJYW7

Device Description : CR MD4.0 GENERAL PLATE 24X30CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904027363 Catalog Number : EJYXA

Device Description : CR MD4.0 GENERAL PLATE 18X24CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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