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
NEUROLOGICA CORP.
GMR40
In Commercial Distribution

  • 10815411020298 ()


  • Computed radiography digital imaging scanner
The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port
Rayence Co., Ltd.
HDI2000
In Commercial Distribution

  • 08800018600139 ()
2.0

  • Dental digital imaging sensor, intraoral
The HDI 2000 is a solid state x-ray imager designed for dental radiographic applications. The HDI 2000 provides digital image capture for conventional film/screen radiographic dental examinations. The device is used to replace radiographic film/screen systems in general dental diagnostic procedures. The captured digital image is transferred to Personal Computer via USB interface port.
Rayence Co., Ltd.
HDI2000
In Commercial Distribution

  • 08800018600122 ()
1.5

  • Dental digital imaging sensor, intraoral
HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600115 ()
2.0

  • Dental digital imaging sensor, intraoral
HDI 1000 is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. Forpatient comfort, theergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
HDI1000
In Commercial Distribution

  • 08800018600108 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600092 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor Pi is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy
Rayence Co., Ltd.
EzSensor Pi
In Commercial Distribution

  • 08800018600085 ()
1.5

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600078 ()
2.0

  • Dental digital imaging sensor, intraoral
EzSensor P is a modern digital imaging solution for intraoral dental radiography. Its advanced CMOS technology provides excellent image quality. For patient comfort, the ergonomic design is based on human intraoral anatomy.
Rayence Co., Ltd.
EzSensor P
In Commercial Distribution

  • 08800018600061 ()
1.5

  • Dental digital imaging sensor, intraoral
HYDRA VISION DIGITAL IMAGING SYSTEM, 80KW SYSTEM
Liebel-Flarsheim Company LLC
705560
Not in Commercial Distribution

  • 10746190002826 ()


  • Stationary uro-gynaecological fluoroscopic x-ray system, digital
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
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
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
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
VILLA SISTEMI MEDICALI SPA
DRF 4343-TS
In Commercial Distribution

  • 08057737122361 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343 FL
In Commercial Distribution

  • 08057737122262 ()


  • Diagnostic x-ray digital imaging system workstation
No Description
VILLA SISTEMI MEDICALI SPA
DRF 4343
In Commercial Distribution

  • 08057737122217 ()


  • Diagnostic x-ray digital imaging system workstation
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
GE MEDICAL SYSTEMS, INC.
5340000-8
In Commercial Distribution

  • 00840682116701 ()


  • Vascular dilator, single-use
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.
5340000-7
In Commercial Distribution

  • 00840682116732 ()


  • Vascular dilator, single-use
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228049166 ()
691424

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228048381 ()
691423

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
V2
In Commercial Distribution

  • 04053228043249 ()
691421

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.
Digiray Corp.
FR31
In Commercial Distribution

  • 08809466040511 ()

  • Height: 13.4 Centimeter
  • Length: 79.5 Centimeter
  • Width: 44.4 Centimeter
  • Weight: 21.5 Kilogram
CG-301

  • Computed radiography digital imaging scanner
The Cassette 18cmx24cm(IP 18cmx24cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA06
In Commercial Distribution

  • 08809466040443 ()

  • Width: 18 Centimeter
  • Length: 24 Centimeter
  • Weight: 0.6 Kilogram


  • X-ray film cassette, manual
The Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA05
In Commercial Distribution

  • 08809466040436 ()

  • Weight: 1.1 Kilogram
  • Length: 30 Centimeter
  • Width: 24 Centimeter


  • X-ray film cassette, manual
The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash.
Digiray Corp.
CA04
In Commercial Distribution

  • 08809466040429 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
  • Weight: 1.9 Kilogram


  • X-ray film cassette, manual
The FireCR Flash can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image. All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution.
Digiray Corp.
FR41
In Commercial Distribution

  • 08809466040412 ()

  • Weight: 21.5 Kilogram
  • Width: 44.4 Centimeter
  • Length: 79.5 Centimeter
  • Height: 13.4 Centimeter
CG-401

  • Computed radiography digital imaging scanner
The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.
Digiray Corp.
FR31
In Commercial Distribution

  • 08809466040313 ()

  • Weight: 21.5 Kilogram
  • Width: 44.4 Centimeter
  • Length: 79.5 Centimeter
  • Height: 13.4 Centimeter
CG-301

  • Computed radiography digital imaging scanner
The Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.
Digiray Corp.
CA02
In Commercial Distribution

  • 08809466040030 ()

  • Width: 30 Centimeter
  • Length: 24 Centimeter
  • Weight: 1.5 Kilogram


  • X-ray film cassette, manual
The Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR.
Digiray Corp.
CA01
In Commercial Distribution

  • 08809466040023 ()

  • Width: 35 Centimeter
  • Length: 43 Centimeter
  • Weight: 1.9 Kilogram


  • X-ray film cassette, manual
The FireCR System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.
Digiray Corp.
FR01
In Commercial Distribution

  • 08809466040016 ()

  • Weight: 30 Kilogram
  • Width: 46.4 Centimeter
  • Length: 70.3 Centimeter
  • Height: 11.7 Centimeter
CG-701

  • Radiography digital imaging scanner
RADIOGRAPHIC RULER
AADCO MEDICAL, INC.
N-365
In Commercial Distribution

  • 00840348526387 ()
N-365

  • X-ray film ruler
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