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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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PaX-i Insight - 08800016400441

Dental Digital X-ray Imaging System functioning Pano Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400441 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i Plus - 08800016400434

Dental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400434 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i Plus - 08800016400427

Dental Digital X-ray Imaging System functioning Pano Image Acquisition
VATECH CO., LTD.
PCH-30CS
In Commercial Distribution

  • 08800016400427 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D - 08800016400205

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(one-shot type) Image Acquisition (Xmaru1501CF / Xmaru0712CF / 1210SGA)
VATECH CO., LTD.
PHT-6500
Not in Commercial Distribution

  • 08800016400205 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

PaX-i3D - 08800016400199

Dental Computed Tomography X-ray System functioning Pano/CT/Ceph(scan type) Image Acquisition (Xmaru1501CF / Xmaru0712CF / Xmaru2301CF)
VATECH CO., LTD.
PHT-6500
In Commercial Distribution

  • 08800016400199 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

EzRay Premium - 08800016400175

Dental Extraoral Source X-ray System (Horizontal Arm Length 900mm)
VATECH CO., LTD.
VEX-S100W
In Commercial Distribution

  • 08800016400175 ()


  • Hand-held intraoral dental x-ray system, digital

EzRay Premium - 08800016400151

Dental Extraoral Source X-ray System (Horizontal Arm Length 600mm)
VATECH CO., LTD.
VEX-S100W
In Commercial Distribution

  • 08800016400151 ()


  • Hand-held intraoral dental x-ray system, digital

VistaPano S Ceph 2.0 - 08800016401967

Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition (Xmaru1501CF-PLUS / Xmaru2602CF)
VATECH CO., LTD.
VistaPano S Ceph
In Commercial Distribution

  • 08800016401967 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

VistaPano S 2.0 - 08800016401950

Digital X-ray Imaging System functioning Pano Image Acquisition (Xmaru1501CF-PLUS)
VATECH CO., LTD.
VistaPano S
In Commercial Distribution

  • 08800016401950 ()


  • Stationary panoramic/tomographic dental x-ray system, digital

EzRay Air 2 Wall - 08800016401929

VEX-S350W X-RAY SYSTEM(900MM)/EZRAY AIR2 W(USA)/MASTER
VATECH CO., LTD.
VEX-S350W
In Commercial Distribution

  • 08800016401929 ()


  • Hand-held intraoral dental x-ray system, digital
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