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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IR 14X17 Portable GOS Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN240
In Commercial Distribution

  • 00817100020230 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 GOS Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN221
In Commercial Distribution

  • 00817100020223 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN220
In Commercial Distribution

  • 00817100020216 ()


  • Diagnostic x-ray digital imaging conversion system
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-02-01-000
In Commercial Distribution

  • 00817100020179 ()


  • Diagnostic x-ray digital imaging system workstation application software
Flat Panel Digital Medical X-Ray Detector.
Imaging Dynamics Company Ltd
1417WCI
In Commercial Distribution

  • 00823073005211 ()

  • Weight: 3.6 Kilogram
  • Height: 15.2 Millimeter
  • Width: 384 Millimeter
  • Length: 460 Millimeter


  • Diagnostic x-ray digital imaging conversion system
Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
Imaging Dynamics Company Ltd
1717WCI
In Commercial Distribution

  • 00823073005112 ()

  • Height: 15.1 Millimeter
  • Width: 460 Millimeter
  • Length: 460 Millimeter
  • Weight: 4.67 Kilogram


  • Diagnostic x-ray digital imaging conversion system
Flat Panel Digital Medical X-Ray Imaging Detector - Wireless
Imaging Dynamics Company Ltd
1417WC
In Commercial Distribution

  • 00823073003217 ()

  • Height: 15.9 Millimeter
  • Width: 417 Millimeter
  • Length: 460 Millimeter
  • Weight: 3.5 Kilogram


  • Diagnostic x-ray digital imaging conversion system
Flat Panel Digital Medical X-Ray Imaging Detector.
Imaging Dynamics Company Ltd
1717TC
In Commercial Distribution

  • 00823073002111 ()

  • Height: 15.5 Millimeter
  • Width: 460 Millimeter
  • Length: 460 Millimeter
  • Weight: 4.0 Kilogram


  • Diagnostic x-ray digital imaging conversion system
CCD Detector
Imaging Dynamics Company Ltd
X3G
In Commercial Distribution

  • 00823073001046 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
CCD Detector
Imaging Dynamics Company Ltd
X3C
In Commercial Distribution

  • 00823073001039 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
CCD Detector
Imaging Dynamics Company Ltd
X3C
In Commercial Distribution

  • 00823073001022 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
CCD Detector
Imaging Dynamics Company Ltd
X4C
In Commercial Distribution

  • 00823073001015 ()

  • Weight: 47.75 Kilogram


  • Stationary basic diagnostic x-ray system, digital
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
iFlashPad 17x17 inch 100um detector
GE Hualun Medical Systems Co., Ltd
4343
In Commercial Distribution

  • 00840682121071 ()


  • Stationary basic diagnostic x-ray system, digital
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
No Description
GE MEDICAL SYSTEMS, INC.
5340000-7
In Commercial Distribution

  • 00840682116732 ()


  • Vascular dilator, single-use
No Description
GE MEDICAL SYSTEMS, INC.
5340000-8
In Commercial Distribution

  • 00840682116701 ()


  • Vascular dilator, single-use
WDR1 Cabinet assembly
GE Hualun Medical Systems Co., Ltd
WDR1
In Commercial Distribution

  • 00840682106139 ()


  • Vascular dilator, single-use
Half Workstation PC Assembly
GE Hualun Medical Systems Co., Ltd
5835165
In Commercial Distribution

  • 00840682146555 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
Ray Co., Ltd
RIO500 (size 2)
In Commercial Distribution

  • 08800003002023 ()


  • Dental digital imaging sensor, intraoral
No Description
Ray Co., Ltd
RIO500 (size 1)
In Commercial Distribution

  • 08800003002016 ()


  • Dental digital imaging sensor, intraoral
No Description
NEUROLOGICA CORP.
GMR40
In Commercial Distribution

  • 10815411020298 ()


  • Computed radiography digital imaging scanner
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1717WCE-GF
In Commercial Distribution

  • 08800018602249 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1717WCE-HS
In Commercial Distribution

  • 08800018602232 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-GF
In Commercial Distribution

  • 08800018602171 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-HS
In Commercial Distribution

  • 08800018602164 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE-HR
In Commercial Distribution

  • 08800018602157 ()


  • Indirect flat panel x-ray detector
X-ray detectors, are wired/wireless digital solid state X-ray detectors that are based on flat panel technology.
Rayence Co., Ltd.
1417WCE
In Commercial Distribution

  • 08800018602140 ()


  • Indirect flat panel x-ray detector
Flat Panel Detector is indicated for digital imaging solution designed for general radio graphic system for human anatomy. It is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Rayence Co., Ltd.
1717SGV
In Commercial Distribution

  • 08800018600634 ()


  • Indirect flat panel x-ray detector
Flat Panel Detector is indicated for digital imaging solution designed for general radio graphic system for human anatomy. It is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Rayence Co., Ltd.
1717SCV
In Commercial Distribution

  • 08800018600627 ()


  • Indirect flat panel x-ray detector
1012WGC is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems
Rayence Co., Ltd.
1012WGC
In Commercial Distribution

  • 08800018600566 ()


  • Indirect flat panel x-ray detector
1417WCC is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems
Rayence Co., Ltd.
1417WCC
In Commercial Distribution

  • 08800018600559 ()


  • Indirect flat panel x-ray detector
1417WGC is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems
Rayence Co., Ltd.
1417WGC
In Commercial Distribution

  • 08800018600542 ()


  • Indirect flat panel x-ray detector
1717SGC is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems
Rayence Co., Ltd.
1717SCC
In Commercial Distribution

  • 08800018600535 ()


  • Indirect flat panel x-ray detector
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