Address:14,Samsung 1-ro 1-gil & #201, 13, Samsung 1-ro 2-gil,Hwaseong-si Gyeonggi,KR
Device Description : 1212FCA is a digital solid state X-ray detector that is based on flat-panel tech 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.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : 2430MCA is a digital mammography X-ray detector that is based on flat-panel tech 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.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : 1717FCC is a digital solid state X-ray detector that is based on flat-panel tech 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.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light 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.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is a orthodontic bracket and is used with orthodontic wire material This product is a orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is an orthodontic bracket and is used with orthodontic wire materia This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is an orthodontic bracket and is used with orthodontic wire materia This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is an orthodontic bracket and is used with orthodontic wire materia This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is an orthodontic bracket and is used with orthodontic wire materi This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is an orthodontic bracket and is used with orthodontic wire materia This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material.
Device Class : 2
Duns Number: 557804458
Premarket Exempt : No
Prescription Use : Yes