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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The FLAATZ 750E detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 750E
In Commercial Distribution

  • 08800018404102 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 760 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 760
In Commercial Distribution

  • 08800018403907 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 560 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 560
In Commercial Distribution

  • 08800018403808 ()


  • Diagnostic x-ray digital imaging conversion system
The EVS 4343 Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.
DRTECH Corporation
EVS 4343
In Commercial Distribution

  • 08800018403501 ()


  • Indirect flat panel x-ray detector
The EVS 4343G Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.
DRTECH Corporation
EVS 4343G
In Commercial Distribution

  • 08800018403402 ()


  • Indirect flat panel x-ray detector
The EVS 3643G Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.
DRTECH Corporation
EVS 3643G
In Commercial Distribution

  • 08800018402702 ()


  • Indirect flat panel x-ray detector
The EVS 3643 detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light.
DRTECH Corporation
EVS 3643
In Commercial Distribution

  • 08800018402603 ()


  • Indirect flat panel x-ray detector
The FLAATZ 601 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 601
In Commercial Distribution

  • 08800018402504 ()


  • Diagnostic x-ray digital imaging conversion system
The FLAATZ 600 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
DRTECH Corporation
FLAATZ 600
In Commercial Distribution

  • 08800018402405 ()


  • Diagnostic x-ray digital imaging conversion system
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
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
Mars1417V-TSI Wireless Flat Panel Detector with only one package
iRay Korea Limited
Mars1417V-TSI
In Commercial Distribution

  • 08800061700015 ()


  • Indirect flat panel x-ray detector
No Description
CANON MEDICAL SYSTEMS CORPORATION
TFP-1216C
In Commercial Distribution

  • 04987670104312 ()


  • Indirect flat panel x-ray detector
DIGITAL RADIOGRAPHY SYSTEM
CANON MEDICAL SYSTEMS CORPORATION
DRAD-3000E
In Commercial Distribution

  • 04987670102196 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CANON MEDICAL SYSTEMS CORPORATION
TFP-1700FL
In Commercial Distribution

  • 04987670100369 ()


  • Indirect flat panel x-ray detector
No Description
CANON MEDICAL SYSTEMS CORPORATION
TFP-1216A
In Commercial Distribution

  • 04987670100345 ()


  • Indirect flat panel x-ray detector
INTERVENTIONAL ANGIOGRAPHY SYSTEM
CANON MEDICAL SYSTEMS CORPORATION
INFX-8000H
In Commercial Distribution

  • 04987670100215 ()


  • Stationary angiographic x-ray system, digital
INTERVENTIONAL ANGIOGRAPHY SYSTEM
CANON MEDICAL SYSTEMS CORPORATION
INFX-8000F
In Commercial Distribution

  • 04987670100208 ()


  • Stationary angiographic x-ray system, digital
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK701G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK701G-WP
In Commercial Distribution

  • 00719192633148 ()
17HK701G-WP

  • Indirect flat panel x-ray detector
Regarding Model Number: "-WP" refers to the inclusion of LG Acquisition Workstation Software ASHK100G to 17HK700G-W, the 510k-approved DXD. "-WP" can be either model number or catalog number.
LG Electronics Inc.
17HK700G-WP
In Commercial Distribution

  • 00719192633131 ()
17HK700G-WP

  • Indirect flat panel x-ray detector
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