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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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Direct Digital Urology Imaging System, 80 kW
Liebel-Flarsheim Company LLC
700560
Not in Commercial Distribution

  • 10746190002475 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
Direct Digital Urology Imaging System, 64kW
Liebel-Flarsheim Company LLC
700559
Not in Commercial Distribution

  • 10746190002468 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
HYDRA VISION DIGITAL IMAGING SYSTEM, 65KW SYSTEM
Liebel-Flarsheim Company LLC
705559
Not in Commercial Distribution

  • 10746190002819 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.
GENERAL MEDICAL MERATE SPA
Pixium 3543EZ
In Commercial Distribution

  • 08054890480154 ()


  • Indirect flat panel x-ray detector
The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.
GENERAL MEDICAL MERATE SPA
Pixium 2430EZ
In Commercial Distribution

  • 08054890480147 ()


  • 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
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
F4335-AW
In Commercial Distribution

  • 08806094744934 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4343-AWM
In Commercial Distribution

  • 08806094458220 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-AWM
In Commercial Distribution

  • 08806094458213 ()


  • Indirect flat panel x-ray detector
The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CWD
In Commercial Distribution

  • 08806090171147 ()


  • Diagnostic x-ray digital imaging conversion system
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CW
In Commercial Distribution

  • 08806088773797 ()


  • Diagnostic x-ray digital imaging conversion system
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CW
In Commercial Distribution

  • 08806088538440 ()


  • Diagnostic x-ray digital imaging conversion system
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4343-AW
In Commercial Distribution

  • 08801643990107 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-AW
In Commercial Distribution

  • 08801643990091 ()


  • Indirect flat panel x-ray detector
The GR40CW and GR40CWC Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CWC
In Commercial Distribution

  • 08801643676568 ()


  • Diagnostic x-ray digital imaging conversion system
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-WV
In Commercial Distribution

  • 08801643431419 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
F4343-AW
In Commercial Distribution

  • 08806095896144 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4343-W
In Commercial Distribution

  • 08806088512266 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S3025-W
In Commercial Distribution

  • 08806088512211 ()


  • Indirect flat panel x-ray detector
Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
S4335-W
In Commercial Distribution

  • 08806086571210 ()


  • Indirect flat panel x-ray detector
The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger.
H&abyz Co., Ltd
HAD1717MCW
In Commercial Distribution

  • 08800070400050 ()
HAD1717MCW

  • Indirect flat panel x-ray detector
The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
F1417MCW
In Commercial Distribution

  • 08800070400043 ()


  • Indirect flat panel x-ray detector
The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
A1417MCW
In Commercial Distribution

  • 08800070400036 ()


  • Indirect flat panel x-ray detector
The A1717MCW/A1417MCW/F1417MCW is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (A1717MCW) or 345.24 x 425.6mm (A1417MCW/F1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&abyz). The A1717MCW/A1417MCW/F1417MCW consists of the following components: Flat Panel Detector, power supply box, cable, battery, and battery recharger.
H&abyz Co., Ltd
A1717MCW
In Commercial Distribution

  • 08800070400029 ()


  • Indirect flat panel x-ray detector
The HAD1717MC is a wired digital flat panel X-ray detector. The HAD1717MC X-ray detector consists of a TFT panel and a scintillator electronic controller, and supports AED (Automatic Exposure Detection) function that can operate without a separate trigger signal. Flat panel sensors for HAD1717MC are fabricated using thin film technology based on amorphous silicon technology, and the sensors are similar to existing photodiode arrays. In this case, each pixel is composed of a photodiode and a thin film transistor (TFT). Amorphous silicon photodiodes are optimized for green wavelengths and can be used in combination with scintillators such as CsI. The incident X-rays are converted into visible light by the scintillator, and the visible light is stored in an internal capacitor through a photodiode. Charges charged to capacitors switch TFT gates of panel matrix (panel matrix) and convert them into digital signals on a line and pass them to the control unit. The digital data generated is then passed to the PC via Ethernet.
H&abyz Co., Ltd
HAD1717MC
In Commercial Distribution

  • 08800070400012 ()


  • Indirect flat panel x-ray detector
The ADD is a Flat Panel Digital X-ray Detector which have 425.04 x 425.6mm (HAD1717MCW) or 345.24 x 425.6mm (HAD1417MCW) effective pixel area. The device communicates by the wired Ethernet and wireless Wi-Fi communication feature. The detector should be integrated with a Console PC and a X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic (the Console PC and X-Ray Generator are not provided from H&Abyz). The ADD consists of the following components: Flat Panel Detector, power supply box, switch box, cable, battery, and battery recharger.
H&abyz Co., Ltd
HAD1417MCW
In Commercial Distribution

  • 08800070400005 ()
HAD1417MCW

  • Indirect flat panel x-ray detector
Mano4343W Wireless Digital Flat Panel Detector k201043 Taicang
iRay Imaging Technology Taicang Limited
Mano4343W
In Commercial Distribution

  • 06972093830175 ()


  • Indirect flat panel x-ray detector
Mars1717V-VSI Wireless Digital Flat Panel Detector k201043 Taicang
iRay Imaging Technology Taicang Limited
Mars1717V-VSI
In Commercial Distribution

  • 06972093830168 ()


  • Indirect flat panel x-ray detector
Mano4336W Wireless Digital Flat Panel Detector K201004 Taicang
iRay Imaging Technology Taicang Limited
Mano4336W
In Commercial Distribution

  • 06972093830151 ()


  • Indirect flat panel x-ray detector
Mars1417V-TSI Wireless Digital Flat Panel Detector k201004 Taicang
iRay Imaging Technology Taicang Limited
Mars1417V-TSI
In Commercial Distribution

  • 06972093830144 ()


  • Indirect flat panel x-ray detector
Mnao4343W Wireless Digital Flat Panel Detector k201043 made in Korea
iRay Imaging Technology Taicang Limited
Mano4343W
In Commercial Distribution

  • 06972093830137 ()


  • Indirect flat panel x-ray detector
Mars1717V-VSI and Mano4336W Wireless Digital Flat Panel Detector k201043
iRay Imaging Technology Taicang Limited
Mars1717V-VSI
In Commercial Distribution

  • 06972093830120 ()


  • Indirect flat panel x-ray detector
Mano4336W Wireless Digital Flat Panel Detector K201004 made in Korea
iRay Imaging Technology Taicang Limited
Mano4336W
In Commercial Distribution

  • 06972093830113 ()


  • Indirect flat panel x-ray detector
Mars1417V-TSI and Mano4336W Wireless Digital Flat Panel Detector
iRay Imaging Technology Taicang Limited
Mars1417V-TSI
In Commercial Distribution

  • 06972093830106 ()


  • Indirect flat panel x-ray detector
Mnao4343W Wireless Digital Flat Panel Detector LTF made in Korea
iRay Imaging Technology Taicang Limited
Mano4343W
In Commercial Distribution

  • 06972093830090 ()


  • Indirect flat panel x-ray detector
Mars1717V-VSI Wireless Digital Flat Panel Detector LTF made in Korea
iRay Imaging Technology Taicang Limited
Mars1717V-VSI
In Commercial Distribution

  • 06972093830083 ()


  • Indirect flat panel x-ray detector
Mano4336W Wireless Digital Flat Panel Detector LTF made in Korea
iRay Imaging Technology Taicang Limited
Mano4336W
In Commercial Distribution

  • 06972093830076 ()


  • Indirect flat panel x-ray detector
Mars1417V-TSI and Mano4336W Wireless Digital Flat Panel Detector LTF
iRay Imaging Technology Taicang Limited
Mars1417V-TSI
In Commercial Distribution

  • 06972093830069 ()


  • Indirect flat panel x-ray detector
No Description
iRay Group
Mars1012V
In Commercial Distribution

  • 06972093830052 ()


  • Indirect flat panel x-ray detector
Mars1717XF-CSI Wireless Digital Flat Panel Detector
iRay Imaging Technology Taicang Limited
Mars1717XF-CSI
In Commercial Distribution

  • 06972093830045 ()


  • Indirect flat panel x-ray detector
Mars1717XF-GSI Wireless Digital Flat Panel Detector
iRay Imaging Technology Taicang Limited
Mars1717XF-GSI
In Commercial Distribution

  • 06972093830038 ()


  • Indirect flat panel x-ray detector
Mars1417XF-CSI Wireless Digital Flat Panel Detector
iRay Imaging Technology Taicang Limited
Mars1417XF-CSI
In Commercial Distribution

  • 06972093830021 ()


  • Indirect flat panel x-ray detector
Mars1417XF-GSI Wireless Digital Flat Panel Detector
iRay Imaging Technology Taicang Limited
Mars1417XF-GSI
In Commercial Distribution

  • 06972093830014 ()


  • Indirect flat panel x-ray detector
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cwe
In Commercial Distribution

  • 06970597830745 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Le
In Commercial Distribution

  • 06970597830721 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 3600RF
In Commercial Distribution

  • 06970597830479 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750Cw
In Commercial Distribution

  • 06970597830363 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 750C
In Commercial Distribution

  • 06970597830349 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800Cw
In Commercial Distribution

  • 06970597830257 ()


  • Portable basic diagnostic x-ray system, digital
No Description
CareRay Digital Medical Technology Co., Ltd.
CareView 1800L
In Commercial Distribution

  • 06970597830240 ()


  • Stationary basic diagnostic x-ray system, digital
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