DRGEM Corporation

Address:116-59, Sanho-daero,Gumi-si Gyeongbuk,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

System, X-Ray, Mobile (IZL) (6) System, X-Ray, Stationary (KPR) (2) Solid State X-Ray Imager (Flat Panel/Digital Imager) (MQB) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

DRGEM - 08800011140878 Catalog Number :

Device Description : 380V3~ / 150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : MQB, KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011140885 Catalog Number :

Device Description : 220-230V~/150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011150006 Catalog Number :

Device Description : 100~240V/125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011150013 Catalog Number :

Device Description : 100~240V/150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011150020 Catalog Number :

Device Description : 100~240V/125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011150037 Catalog Number :

Device Description : 100~240V/150kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011150082 Catalog Number :

Device Description : 100~240V~120kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011150099 Catalog Number :

Device Description : 110~240V~120kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011170004 Catalog Number :

Device Description : Digital Imaging Software

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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