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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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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

Optima - 00195278840233

XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00195278840233 ()


  • Stationary basic diagnostic x-ray system, digital

Discovery - 00195278840226

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

  • 00195278840226 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00195278832252

Galaxy 2.0 Wall Stand(Insert Left)
GE Hualun Medical Systems Co., Ltd
VMWS-2
In Commercial Distribution

  • 00195278832252 ()


  • Stationary basic diagnostic x-ray system, digital

Definium - 00195278913807

Definium Pace Select ET System UDI
GE Hualun Medical Systems Co., Ltd
Pace Select ET
In Commercial Distribution

  • 00195278913807 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00195278901880

Gemini Tube Stand
GE Hualun Medical Systems Co., Ltd
GCTS-C1
In Commercial Distribution

  • 00195278901880 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 08806095799643

The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GF85-SP
In Commercial Distribution

  • 08806095799643 ()


  • Stationary basic diagnostic x-ray system, digital
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