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) (6) System, Image Processing, Radiological (LLZ) (2)

Premarket Exempt

No Yes

Clear

Exprimer - 08800018406007 Catalog Number :

Device Description : The EVS 3643W Digital X-ray detector is indicated for digital imaging solution d The EVS 3643W Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Exprimer - 08800018406106 Catalog Number :

Device Description : The EVS 3643WG Digital X-ray detector is indicated for digital imaging solution The EVS 3643WG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Exprimer - 08800018406205 Catalog Number :

Device Description : The EXPD 3643P Digital X-ray detector is indicated for digital imaging solution The EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Exprimer - 08800018406304 Catalog Number :

Device Description : The EXPD 4343P Digital X-ray detector is indicated for digital imaging solution The EXPD 4343P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Exprimer - 08800018406403 Catalog Number :

Device Description : The EVS 3643WP Digital X-ray detector is indicated for digital imaging solution The EVS 3643WP Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

Exprimer - 08800018406502 Catalog Number :

Device Description : The EVS 4343WP Digital X-ray detector is indicated for digital imaging solution The EVS 4343WP Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : MQB

Prescription Use : Yes

Device Count : 1

EConsole1 - 08800018410004 Catalog Number :

Device Description : The Econsole1 is indicated for use in general radiographic images of human anatomy.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

RConsole1 - 08800018411001 Catalog Number :

Device Description : The Rconsole1 is intended for use with mammographic images acquired using digita The Rconsole1 is intended for use with mammographic images acquired using digital breast x-ray systems.

Device Class : 2

Duns Number: 689842626

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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