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The 2430TCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screening mammography. Xmaru W is an integrated software solution indicated for use with the 2430TCA detector.

2430TCA 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 TFT 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. 2430TCA detector is connected to the viewing station via a LAN cable.

Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology. The wireless LAN (IEEE 802.11 n/ac) communication signals images captured to the system and improves the user operability through high speed processing. These radiographic image detectors are processing unit consist of a scintillator coupled to an TFT sensor. The flat-panel detectors need to be integrated with an x-ray generator (not part of the submission), so it can be utilized to capture and digitize x-ray images for radiographic diagnosis. 1717WCE. 1717WCE-HR. 1717WCE-HS. 1717WCE-GF includes the software (firmware) of basic level of concern. It's the same Image Acquisition and Operating Software used for the predicate device is used but modified to include additional detector models in comparison with the predicate device. Full software documentation has been submitted, as well as the necessary sections to demonstrate device cybersecurity. The RAW files can be further processed as DICOM compatible image files by separate consol SW (K190866, XmaruView V1 / Rayence Co.,Ltd) for a radiographic diagnosis and analysis. 1717WCE is the basic model. 1717WCE-HR is identical with the basic model except for pixel pitch not related to safety. 1717WCE-HS is identical with the basic model except for marking of sheet. 1717WCE-GF is identical with the basic model except for case color and pixel pitch.

0909FCC and 0909FCC-HS are indicated for digital imaging solution designed including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). The detectors are intended to replace the x-ray imager on film based radiographic diagnostic systems. Not to be used for mammography.

0909FCC and 0909FCC-HS are digital solid state X-ray detectors based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to Indium Ginc 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 Lite) for a radiographic diagnosis and analysis. 0909FCC is a basic model. 0909FCC-HS is identical with a basic model except for marking of sheet not related to safety. 0909 FCC and 0909 FCC-HS are intended to capture dynamic images. The Xmaru RF lite imaging software is included in the system but the computer that receives the digital images is not provided with the system. 0909FCC and 0909FCC-HS are compatible with the X-ray generator, HTC-35B by Poskom Co.,Ltd, which is not provided with the system.

Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology. The wireless LAN (IEEE 802.11 n/ac) communication signals images captured to the system and improves the user operability through high speed processing. These radiographic image detectors are processing unit consist of a scintillator coupled to an a-Si TFT sensor. These devices need to be integrated with a static radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The revised 510k Summary specified that 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF includes the software (firmware) of MODERATE level of concern. It's the same Image Acquisition and Operating Software used for the predictive device is used but modified to include additional detector models in comparison with the predicate device. The RAW files can be further processed as DICOM compatible image files by separate consol SW (K190866, XmaruView V1 / Rayence Co.,Ltd) for a radiographic diagnosis and analysis. The imaging software XMaru View V1 is not part of the subject device. 1417WCE is the basic model. 1417WCE-HR is identical with the basic model except for the pixel pitch size. 417WCE-HS is identical with the basic model except for the case color. 1417WCE-GF is identical with the basic model except for the case color and the pixel pitch size. The differences are not safety related.

Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Columnstructurized 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. The 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 connected to a viewing station by ethernet connection cable. There is no wireless option available. The 0909 FCB and 1212FCA SSXI detectors should be tested and used with compatible X-ray generators which are not part of the imaging receptor device package.

The 2430MCA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for a mammographic system. It is intended to replace film or screen based mammographic systems in screening mammography. Xmaru W is an integrated software solution indicated for use with the 2430MCA 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.

1717FCC is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

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.

1212FCA is indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.

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 Xray 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.

1717SCV and 1717SGV X-ray detectors, 127um and 140um, are indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

1717SCV / 1717SGV 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. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis. 1717SCV and 1717SGV have the same Hardware, Software and components. The type of scintillator layer are different: Cesium Iodide for 1717SCV and Gadolinium Oxsulfide for 1717SGV. Scintillator is a phosphor that produces scintillations. The subject detectors are not wireless, but they are connected to a viewing station by ethernet connection. Also, the subject detectors have an Automatic Exposure Control (AEC) feature. The RAW files can be further processed as DICOM compatible image files by separate console SW (K190866 / Xmaruview V1 (Xmaru Chiroview, Xmaru Podview)/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis. The software used with the subject detectors is the same as the software XmaruView V1 used with the predicate K190866.

Xmaru View V1(Xmaru Chiroview or Xmaru Podview) software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, and measurements. Ymaru View V (Xmaru Chiroview or Xmaru Podview) is not approved for mammography and is meant to be used by qualified medical personnel only. Xmaru Chiroview or Xmaru Podview) is complying with DICOM standards to assure optimum communications between network systems.

XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography. XmaruView V1 performs connects with Flat-Panel Detectors and Generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.