WIDE corporation

Address:15F, The First Tower III,Hwaseong-si Gyeonggi,KR

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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) (10)

Premarket Exempt

Clear

MX50T - 08809241513001 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical images.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

MX50N - 08809241513018 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical images.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

MX30N - 08809241513025 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical images.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

CX50N - 08809241513032 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical images.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

CX30N - 08809241513049 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical images.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

CX20N - 08809241513056 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical images.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

6MP - 08809241513063 Catalog Number :

Device Description : Flat Panel hi-resolution LCD monitor system for displaying digital medical images.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

CX50N - 08809241513070 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical image Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

MX50N - 08809241513087 Catalog Number :

Device Description : Flat panel hi-resolution LCD monitor system for displaying digital medical image Flat panel hi-resolution LCD monitor system for displaying digital medical images.(Tomosynthesis)

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : Yes

Device Count : 1

CW120N - 08809241513124 Catalog Number :

Device Description : CW120N LCD Monitor System is intended to be used in displaying and viewing digit CW120N LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.

Device Class : 2

Duns Number: 688285899

Premarket Exempt : No

Product Code : PGY

Prescription Use : No

Device Count : 1

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