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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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-. Magnfication : 5 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W )
Huvitz Co., Ltd.
HS-5000
In Commercial Distribution

  • 08800019600008 ()
HS-5000

  • Ophthalmic examination slit lamp
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-GF
In Commercial Distribution

  • 08800018602171 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-HS
In Commercial Distribution

  • 08800018602164 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-HR
In Commercial Distribution

  • 08800018602157 ()


  • Indirect flat panel x-ray detector
The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Column-structurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
Rayence Co., Ltd.
0909FCB
In Commercial Distribution

  • 08800018600900 ()


  • Indirect flat panel x-ray detector
1717FCC 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 amorphous silicon (a-Si) / Indium Gallium Zinc Oxide (IGZO) on TFT sensor. This device is connected to the user PC via wired LAN (ethernet cable) and it needs to be integrated with a radiographic imaging system. It does not operate as an X-ray generator controller but can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW(Xmaru RF) for a radiographic diagnosis and analysis.
Rayence Co., Ltd.
1717FCC
Not in Commercial Distribution

  • 08800018600887 ()


  • Indirect flat panel x-ray detector
2430MCA is a digital mammography X-ray detector that is based on flat-panel technology. This mammographic image detector and processing unit consists of a CsI scintillator coupled to a CMOS sensor. This device needs to be integrated with a mammographic imaging system. It can be utilized to capture and digitalize X-ray images for mammographic screening. The RAW files can be further processed as DICOM compatible image files by separate console SW, Xmaru W for a mammographic screening. 2430MCA detector is connected by wire to a viewing station via ethernet connection.
Rayence Co., Ltd.
2430MCA
In Commercial Distribution

  • 08800018600726 ()


  • Indirect flat panel x-ray detector
1212FCA 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 IGZO TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis. The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection.
Rayence Co., Ltd.
1212FCA
In Commercial Distribution

  • 08800018600641 ()


  • Indirect flat panel x-ray detector
Flat Panel Detector is indicated for digital imaging solution designed for general radio graphic system for human anatomy. It is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Rayence Co., Ltd.
1717SGV
In Commercial Distribution

  • 08800018600634 ()


  • Indirect flat panel x-ray detector
Flat Panel Detector is indicated for digital imaging solution designed for general radio graphic system for human anatomy. It is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Rayence Co., Ltd.
1717SCV
In Commercial Distribution

  • 08800018600627 ()


  • Indirect flat panel x-ray detector
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