Barco NV

Address:35 PRESIDENT KENNEDYPARK,KORTRIJK West-Vlaanderen,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

Display, diagnostic radiology (PGY) (6) System, image processing, radiological (LLZ) (4)

Premarket Exempt

No Yes

Clear

Nio 5MP LED - 05415334000117 Catalog Number : K9300351B

Device Description : MDNG-5221 BB

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Coronis 5MP Mammo - 05415334000124 Catalog Number :

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Nio 5.8MP - 05415334000131 Catalog Number : K9300360A

Device Description : MDNC-6121

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

Nio 2MP - 05415334000148 Catalog Number :

Device Class : 2

Duns Number: 371618773

Premarket Exempt : Yes

Product Code : PGY

Prescription Use : Yes

Device Count : 1

Barco Mammo Tomosynthesis - 05415334000155 Catalog Number :

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Coronis 3MP LED - 05415334000162 Catalog Number :

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Coronis 5MP - 05415334000179 Catalog Number : K9301540A

Device Description : MDCG-5221 CB

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

Coronis 5MP - 05415334000186 Catalog Number : K9301540B

Device Description : MDCG-5221 CB

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

Coronis 5MP - 05415334000193 Catalog Number : K9301541A

Device Description : MDCG-5221 BB

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

Coronis 5MP - 05415334000209 Catalog Number : K9301541B

Device Description : MDCG-5221 BB

Device Class : 2

Duns Number: 371618773

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

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