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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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*Line power rating: 480V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-8A
In Commercial Distribution

  • 08800011140175 ()


  • Stationary basic diagnostic x-ray system, digital
*Line power rating: 480V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-5A
In Commercial Distribution

  • 08800011140151 ()


  • Stationary basic diagnostic x-ray system, digital
100-240V~ / 125kV
DRGEM Corporation
GXR-U32SD
In Commercial Distribution

  • 08800011140137 ()


  • Stationary basic diagnostic x-ray system, digital
110-120V~ / 125kV
DRGEM Corporation
GXR-C40SD
In Commercial Distribution

  • 08800011140113 ()


  • Stationary basic diagnostic x-ray system, digital
400V3~ / 150kV
DRGEM Corporation
GXR-82SD
In Commercial Distribution

  • 08800011140090 ()


  • Stationary basic diagnostic x-ray system, digital
400V3~ / 150kV
DRGEM Corporation
GXR-52SD
In Commercial Distribution

  • 08800011140076 ()


  • Stationary basic diagnostic x-ray system, digital
220-230V~ / 150kV
DRGEM Corporation
GXR-40SD
In Commercial Distribution

  • 08800011140069 ()


  • Stationary basic diagnostic x-ray system, digital
*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-8A
In Commercial Distribution

  • 08800011140021 ()


  • Stationary basic diagnostic x-ray system, digital
*Line power rating: 400V3~ *MAX Tube voltage: 150kV
DRGEM Corporation
DIAMOND-5A
In Commercial Distribution

  • 08800011140007 ()


  • Stationary basic diagnostic x-ray system, digital
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
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