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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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DRGEM - 08800011140076

400V3~ / 150kV
DRGEM Corporation
GXR-52SD
In Commercial Distribution

  • 08800011140076 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140069

220-230V~ / 150kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140069 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140021

*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-8A
In Commercial Distribution

  • 08800011140021 ()


  • Stationary basic diagnostic x-ray system, digital

DRGEM - 08800011140007

*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-5A
In Commercial Distribution

  • 08800011140007 ()


  • Stationary basic diagnostic x-ray system, digital

VISION - 08606102809132

Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels.
VISARIS DOO
Vision V
In Commercial Distribution

  • 08606102809132 ()


  • Stationary basic diagnostic x-ray system, digital

VISION - 08606102809125

Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels.
VISARIS DOO
Vision X
In Commercial Distribution

  • 08606102809125 ()


  • Stationary basic diagnostic x-ray system, digital

VISION - 08606102809118

Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels.
VISARIS DOO
Vision U
In Commercial Distribution

  • 08606102809118 ()


  • Stationary basic diagnostic x-ray system, digital

VISION - 08606102809101

Visaris Vision combines our Visaris Avanse® cleared PACS software (K150725) with all the other components required to make a complete digital diagnostic X‐ray system, including tube stands, tube heads, collimators, generators, tables, and (already cleared) digital X‐ray panels.
VISARIS DOO
Vision C
In Commercial Distribution

  • 08606102809101 ()


  • Stationary basic diagnostic x-ray system, digital

Discovery - 00840682138598

Discovery XR656 HD System
GE Hualun Medical Systems Co., Ltd
XR656 HD
In Commercial Distribution

  • 00840682138598 ()


  • Stationary basic diagnostic x-ray system, digital

Discovery - 00840682136709

XR656HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR656 HD Upgrade
In Commercial Distribution

  • 00840682136709 ()


  • Stationary basic diagnostic x-ray system, digital
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