Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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1210SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system.
Rayence Co., Ltd.
1210SGA
In Commercial Distribution

  • 08800018600238 ()


  • Indirect flat panel x-ray detector
The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port
Rayence Co., Ltd.
HDI2000
In Commercial Distribution

  • 08800018600139 ()
2.0

  • Dental digital imaging sensor, intraoral
The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.
Rayence Co., Ltd.
HDI2000
In Commercial Distribution

  • 08800018600122 ()
1.5

  • Dental digital imaging sensor, intraoral
HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600115 ()
2.0

  • Dental digital imaging sensor, intraoral
HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600108 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600092 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600085 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600078 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600061 ()
1.5

  • Dental digital imaging sensor, intraoral
No Description
DRTECH Corporation
EXPD 3643NP
In Commercial Distribution

  • 08800018430903 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 3643NU
In Commercial Distribution

  • 08800018430804 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 3643U1
In Commercial Distribution

  • 08800018430705 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 3643N
In Commercial Distribution

  • 08800018430606 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 3643N1
In Commercial Distribution

  • 08800018430507 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 4343NP
In Commercial Distribution

  • 08800018430408 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 4343NU
In Commercial Distribution

  • 08800018430309 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 4343U1
In Commercial Distribution

  • 08800018430200 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 4343N
In Commercial Distribution

  • 08800018430101 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 4343N1
In Commercial Distribution

  • 08800018430002 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 114PG
In Commercial Distribution

  • 08800018408803 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 114P
In Commercial Distribution

  • 08800018408704 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 114G
In Commercial Distribution

  • 08800018408605 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 114
In Commercial Distribution

  • 08800018408506 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 4357P
In Commercial Distribution

  • 08800018408001 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EXPD 4357
In Commercial Distribution

  • 08800018407905 ()


  • Indirect flat panel x-ray detector
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG 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. It is intended for both adult and pediatric populations.
DRTECH Corporation
EXPD 86PG
In Commercial Distribution

  • 08800018407608 ()


  • Indirect flat panel x-ray detector
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG 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. It is intended for both adult and pediatric populations.
DRTECH Corporation
EXPD 86P
In Commercial Distribution

  • 08800018407509 ()


  • Indirect flat panel x-ray detector
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG 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. It is intended for both adult and pediatric populations.
DRTECH Corporation
EXPD 129PG
In Commercial Distribution

  • 08800018407400 ()


  • Indirect flat panel x-ray detector
The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG 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. It is intended for both adult and pediatric populations.
DRTECH Corporation
EXPD 129P
In Commercial Distribution

  • 08800018407301 ()


  • Indirect flat panel x-ray detector
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.
DRTECH Corporation
EVS 4343WP
In Commercial Distribution

  • 08800018406502 ()


  • Indirect flat panel x-ray detector
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.
DRTECH Corporation
EVS 3643WP
In Commercial Distribution

  • 08800018406403 ()


  • Indirect flat panel x-ray detector
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.
DRTECH Corporation
EXPD 4343P
In Commercial Distribution

  • 08800018406304 ()


  • Indirect flat panel x-ray detector
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.
DRTECH Corporation
EXPD 3643P
In Commercial Distribution

  • 08800018406205 ()


  • Indirect flat panel x-ray detector
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.
DRTECH Corporation
EVS 3643WG
In Commercial Distribution

  • 08800018406106 ()


  • Indirect flat panel x-ray detector
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.
DRTECH Corporation
EVS 3643W
In Commercial Distribution

  • 08800018406007 ()


  • Indirect flat panel x-ray detector
The EVS 4343WG 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.
DRTECH Corporation
EVS 4343WG
In Commercial Distribution

  • 08800018405901 ()


  • Indirect flat panel x-ray detector
The EVS 4343W 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.
DRTECH Corporation
EVS 4343W
In Commercial Distribution

  • 08800018405802 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EVS 3643AG
In Commercial Distribution

  • 08800018405703 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EVS 3643A
In Commercial Distribution

  • 08800018405604 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EVS 4343AG
In Commercial Distribution

  • 08800018405505 ()


  • Indirect flat panel x-ray detector
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