DRTECH Corporation

Address:Suite No.1, 2 Floor / Suite No.2, 3 Floor, 29, Dunchon-daero 541beon-gil,Seongnam-si Gyeonggi,KR

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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) (8) Full Field Digital,System,X-Ray,Mammographic (MUE) (2)

Premarket Exempt

No Yes

Clear

RoseM - 08800018401606 Catalog Number :

Device Description : The RSM 1824C is designed for use in Digital X-ray Images of woman breast diagno The RSM 1824C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography), which intended to be used in radiographic film/screen systems in general-purpose diagnostic procedures. The system can be applied wherever traditional X-ray screen-film cassettes are currently used.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

RoseM - 08800018401903 Catalog Number :

Device Description : The RSM 2430C is designed for use in Digital X-ray Images of woman breast diagno The RSM 2430C is designed for use in Digital X-ray Images of woman breast diagnosis (mammography), which intended to be used in radiographic film/screen systems in general-purpose diagnostic procedures. The system can be applied wherever traditional X-ray screen-film cassettes are currently used.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MUE

Prescription Use : No

Device Count : 1

FLAATZ - 08800018402405 Catalog Number :

Device Description : The FLAATZ 600 detector is a direct conversion device in the form of a square pl The FLAATZ 600 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : Yes

Product Code : MQB

Prescription Use : No

Device Count : 1

FLAATZ - 08800018402504 Catalog Number :

Device Description : The FLAATZ 601 detector is a direct conversion device in the form of a square pl The FLAATZ 601 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : Yes

Product Code : MQB

Prescription Use : No

Device Count : 1

Exprimer - 08800018402603 Catalog Number :

Device Description : The EVS 3643 detector is an indirect conversion device in the form of a square p The EVS 3643 detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Exprimer - 08800018402702 Catalog Number :

Device Description : The EVS 3643G Detector is an indirect conversion device in the form of a square The EVS 3643G Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Exprimer - 08800018403402 Catalog Number :

Device Description : The EVS 4343G Detector is an indirect conversion device in the form of a square The EVS 4343G Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

Exprimer - 08800018403501 Catalog Number :

Device Description : The EVS 4343 Detector is an indirect conversion device in the form of a square p The EVS 4343 Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : No

Device Count : 1

FLAATZ - 08800018403808 Catalog Number :

Device Description : The FLAATZ 560 detector is a direct conversion device in the form of a square pl The FLAATZ 560 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitivephotoconductor.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : Yes

Product Code : MQB

Prescription Use : No

Device Count : 1

FLAATZ - 08800018403907 Catalog Number :

Device Description : The FLAATZ 760 detector is a direct conversion device in the form of a square pl The FLAATZ 760 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitivephotoconductor.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : Yes

Product Code : MQB

Prescription Use : No

Device Count : 1

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