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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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NA - 08717213052246

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170537-06
Not in Commercial Distribution

  • 08717213052246 ()


  • Radiation therapy software

NA - 08717213052239

Oncentra External Beam/Oncentra Brachy v4.5.3
Nucletron B.V.
170003-25
Not in Commercial Distribution

  • 08717213052239 ()


  • Radiation therapy software

NA - 08717213051881

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-05
Not in Commercial Distribution

  • 08717213051881 ()


  • Radiation therapy software

NA - 08717213051843

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-24
Not in Commercial Distribution

  • 08717213051843 ()


  • Radiation therapy software

NA - 08717213051782

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170537-04
Not in Commercial Distribution

  • 08717213051782 ()


  • Radiation therapy software

NA - 08717213051775

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170003-23
Not in Commercial Distribution

  • 08717213051775 ()


  • Radiation therapy software

NA - 08717213051294

Oncentra External Beam/Oncentra Brachy v4.5.2
Nucletron B.V.
170730
Not in Commercial Distribution

  • 08717213051294 ()


  • Radiation therapy software

QuantX - B80731

QuantX is a software program that is used to view and analyze patient breast images.
QLARITY IMAGING, LLC
Breast MRI SE
Not in Commercial Distribution

  • B80731 ()
3

  • Radiological PACS software

QuantX - B80711

QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.
QLARITY IMAGING, LLC
Breast MRI
In Commercial Distribution

  • B80711 ()
1

  • Radiological PACS software

QuantX - B80721

The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution

  • B80721 ()
2

  • Radiological PACS software
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