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

Generator, High-Voltage, X-Ray, Diagnostic (IZO) (9) System, X-Ray, Stationary (KPR) (1)

Premarket Exempt

No Yes

Clear

DRGEM - 08800011110277 Catalog Number :

Device Description : *Line power rating: 220-230V~*MAX tube voltage: 150kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110284 Catalog Number :

Device Description : *Line power rating: 110-120V~*MAX tube voltage: 150kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110291 Catalog Number :

Device Description : *Line power rating: 220-230V~*MAX tube voltage: 125kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110307 Catalog Number :

Device Description : *Line power rating: 220-230V~*MAX tube voltage: 150kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110314 Catalog Number :

Device Description : *Line power rating: 110-120V~*MAX tube voltage: 150kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110321 Catalog Number :

Device Description : *Line power rating: 220-230V~*MAX tube voltage: 125kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110338 Catalog Number :

Device Description : *Line power rating: 220-230V~*MAX tube voltage: 150kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110345 Catalog Number :

Device Description : *Line power rating: 100-240V~*MAX tube voltage: 150kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011110352 Catalog Number :

Device Description : *Line power rating: 100-240V~*MAX tube voltage: 150kV

Device Class : 1

Duns Number: 688477319

Premarket Exempt : Yes

Product Code : IZO

Prescription Use : Yes

Device Count : 1

DRGEM - 08800011120009 Catalog Number :

Device Description : 220-230V~ / 125kV

Device Class : 2

Duns Number: 688477319

Premarket Exempt : No

Product Code : KPR

Prescription Use : Yes

Device Count : 1

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