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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No Description
DRTECH Corporation
EVS 3643A
In Commercial Distribution

  • 08800018405604 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EVS 4343AG
In Commercial Distribution

  • 08800018405505 ()


  • Indirect flat panel x-ray detector
No Description
DRTECH Corporation
EVS 4343A
In Commercial Distribution

  • 08800018405406 ()


  • Indirect flat panel x-ray detector
The EVS 2430GW Digital X-ray detector is designed as a digital imaging solution, for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures.
DRTECH Corporation
EVS 2430GW
In Commercial Distribution

  • 08800018404508 ()


  • Indirect flat panel x-ray detector
The EVS 2430W Digital X-ray detector is designed as a digital imaging solution, for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures.
DRTECH Corporation
EVS 2430W
In Commercial Distribution

  • 08800018404409 ()


  • Indirect flat panel x-ray detector
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
No Description
GE MEDICAL SYSTEMS, INC.
3543
In Commercial Distribution

  • 00840682120807 ()


  • Indirect flat panel x-ray detector
No Description
GE MEDICAL SYSTEMS, INC.
2530
In Commercial Distribution

  • 00840682120784 ()


  • 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
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
A1717MCW
In Commercial Distribution

  • 08800070400029 ()


  • 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
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 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
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.
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
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
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
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
Solid State X-ray Imager (Flat Panel / Digital Imager)
Radisen Co., Ltd.
1417MG
In Commercial Distribution

  • 08800099500090 ()
PEDRA-1417MG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel / Digital Imager)
Radisen Co., Ltd.
1417MC
In Commercial Distribution

  • 08800099500083 ()
PEDRA-1417MC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
17FG
In Commercial Distribution

  • 08800099500069 ()
PEDRA-17FG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
17FC
In Commercial Distribution

  • 08800099500052 ()
PEDRA-17FC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1417FG
In Commercial Distribution

  • 08800099500045 ()
PEDRA-1417FG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1417FC
In Commercial Distribution

  • 08800099500038 ()
PEDRA-1417FC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1717DTG
In Commercial Distribution

  • 08800099500021 ()
PEDRA-1717DTG

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
1717DTC
In Commercial Distribution

  • 08800099500014 ()
PEDRA-1717DTC

  • Indirect flat panel x-ray detector
Solid State X-ray Imager (Flat Panel Detector / Digital X-ray Imager)
Radisen Co., Ltd.
17F
In Commercial Distribution

  • 08800099500007 ()
PEDRA-17F

  • Indirect flat panel x-ray detector
6.3KG SPRING ARM & MOBLIE STAND
AADCO MEDICAL, INC.
OS-800
In Commercial Distribution

  • 00840348502244 ()
OS-800

  • Radiation shielding panel, portable/mobile
ADJUST-A-HEIGHT PIVOTING OVER-TABLE BARRIER DUAL CUTOUT
AADCO MEDICAL, INC.
OS-615D
In Commercial Distribution

  • 00840348501841 ()
OS-615D

  • Radiation shielding panel, portable/mobile
ADJUST-A-HEIGHT PIVOTING OVER TABLE BARRIER WITH CUTOUT
AADCO MEDICAL, INC.
OS-615
In Commercial Distribution

  • 00840348501834 ()
OS-615

  • Radiation shielding panel, portable/mobile
TRAPEZOID MOBILE BARRIER
AADCO MEDICAL, INC.
S-750
In Commercial Distribution

  • 00840348509564 ()
S-750

  • Radiation shielding panel, portable/mobile
SHATTERPROOF GLASS REG WIDE MOBILE BARRIER 2.0MM
AADCO MEDICAL, INC.
S-707A
In Commercial Distribution

  • 00840348509557 ()
S-707A

  • Radiation shielding panel, portable/mobile
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