VIEWORKS CO., LTD.

Address:41-3, Burim-ro 170beon-gil, Dongan-gu,Anyang-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

Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (10)

Premarket Exempt

No Yes

Clear

FXRD-1717N - 08809394330203 Catalog Number :

Device Class : 2

Duns Number: 688274778

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

FXRD-1717N - 08809394330210 Catalog Number :

Device Class : 2

Duns Number: 688274778

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

VIVIX-S 1417N - 08809394330227 Catalog Number :

Device Class : 2

Duns Number: 688274778

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

VIVIX-S 1417N - 08809394330234 Catalog Number :

Device Class : 2

Duns Number: 688274778

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

VIVIX-S 1717V - 08809394330241 Catalog Number :

Device Description : Solid State X-ray Imager (Flat panel/ digital imager)

Device Class : 2

Duns Number: 688274778

Premarket Exempt : Yes

Product Code : MQB

Prescription Use : Yes

Device Count : 1

VIVIX-S 1717V - 08809394330258 Catalog Number :

Device Description : Solid State X-ray Imager (flat panel/digital imager)

Device Class : 2

Duns Number: 688274778

Premarket Exempt : Yes

Product Code : MQB

Prescription Use : Yes

Device Count : 1

VIVIX-S 1751S - 08809394330289 Catalog Number :

Device Description : Solid State X-ray Imager (Flat Panel/Digital Imager)

Device Class : 2

Duns Number: 688274778

Premarket Exempt : Yes

Product Code : MQB

Prescription Use : No

Device Count : 1

VIVIX-S 2530VAW - 08809394330296 Catalog Number :

Device Description : Flat Panel Detector of 25 cm by 30 cm size. Wireless

Device Class : 2

Duns Number: 688274778

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

VIVIX-S 2530VAW PLUS - 08809394330302 Catalog Number :

Device Description : Flat Panel Detector, wireless25cm by 30 cm of size

Device Class : 2

Duns Number: 688274778

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

VIVIX-S 3643VAW - 08809394330319 Catalog Number :

Device Description : Flat Panel Detector, wireless36cm by 43 cm of size

Device Class : 2

Duns Number: 688274778

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

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