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) (6) Cassette, radiographic film (IXA) (4)

Premarket Exempt

No Yes

Clear

CR MD4.0T GENERAL SET - 05414904017340 Catalog Number : EVHAW

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

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MM3.0 EXTREMITIES CASSETTE - 05414904018194 Catalog Number : EU5UH

Device Description : CR MM3.0 EXTR CAS 24X30CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CR MM3.0 EXTREMITIES CASSETTE - 05414904018200 Catalog Number : EU5TF

Device Description : CR MM3.0 EXTR CAS 18X24CM

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

CURIX OPTHOS H - 05414904024430 Catalog Number : 35ZQ7

Device Description : CURIX CAS EU+OPTHOS H 35X43

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

MAMORAY DETAIL R - 05414904024539 Catalog Number : 36CPQ

Device Description : MAMORAY CASSETTE / DETAIL R

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

MAMORAY DETAIL R - 05414904024690 Catalog Number : 36COO

Device Description : MAMORAY CASSETTE / DETAIL R

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

MAMORAY DETAIL R - 05414904026007 Catalog Number : 36CQS

Device Description : MAMORAY CASSETTE / DETAIL R

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : IXA

Prescription Use : Yes

Device Count : 1

CR MD4.0R GENERAL SR SET - 05414904026571 Catalog Number : E49V7

Device Description : CR MD4.0R GENERAL SR 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 SR SET - 05414904026588 Catalog Number : E49WA

Device Description : CR MD4.0R GENERAL SR 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 FLFS SET - 05414904026595 Catalog Number : E49XC

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

Device Class : 2

Duns Number: 374444883

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

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