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) (9) Camera, multi format, radiological (LMC) (1)

Premarket Exempt

No Yes

Clear

CRYSTAL-M IMAGER - 05414904161487 Catalog Number : 5YGOF

Device Description : CRYSTAL-M IMAGER

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : LMC

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904172384 Catalog Number : 5ZV25

Device Description : CR MD4.0 GENERAL PLATE 17X17 INCH

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD4.0 GENERAL PLATE - 05414904175811 Catalog Number : 51BTM

Device Description : CR MD4.0 GENERAL PLATE 14X34 INCH

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

DR 400 - 05414904176252 Catalog Number : 51FS1

Device Description : DR 400 SYSTEM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD1.0F GENERAL PLATE - 05414904180389 Catalog Number : 512HY

Device Description : CR MD1.0F GEN.PL. 15X30 INS.35X43CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MD1.0F GENERAL CASSETTE - 05414904180600 Catalog Number : 512K3

Device Description : CR MD1.0F GEN.CAS 15X30 INS.35X43CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR HD5.0S GENERAL DETECTOR - 05414904188880 Catalog Number : 53LZK

Device Description : CR HD5.0S GENERAL DETECTOR 35X43 CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR HD5.0S GENERAL DETECTOR - 05414904188897 Catalog Number : 53L1M

Device Description : CR HD5.0S GENERAL DETECTOR 24X30 CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR HD5.0S GENERAL DETECTOR - 05414904188903 Catalog Number : 53L2O

Device Description : CR HD5.0S GENERAL DETECTOR 18X24 CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR HD5.0S GENERAL CASSETTE - 05414904188910 Catalog Number : 53L3Q

Device Description : CR HD5.0S GENERAL CASSETTE 35X43 CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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