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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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Optellum Virtual Nodule Clinic - B816VNC2P10

Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with incidentally detected pulmonary nodules. The software assists the user with (1) management and tracking of patients with indeterminate pulmonary nodules (IPNs), available to all users and (2) a computer-aided diagnosis (CADx) function that takes a user-selected ROI and uses artificial intelligence to synthesize its morphological characteristics into a single value, the Optellum Lung Cancer Predictor (LCP) Score, only available to radiologists and pulmonologists.
OPTELLUM LTD
2.1.0
In Commercial Distribution

  • B816VNC2P10 ()
N/A

  • CT system application software

VEA Align - 03663999000337

No Description
EOS IMAGING
2.1
In Commercial Distribution

  • 03663999000337 ()


  • Basic diagnostic x-ray system application software

VEA Align - 03663999000290

No Description
EOS IMAGING
1.0
Not in Commercial Distribution

  • 03663999000290 ()


  • Basic diagnostic x-ray system application software

sterEOS - 03663999000153

No Description
EOS IMAGING
1.10
In Commercial Distribution

  • 03663999000153 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000054

sterEOS workstation software
EOS IMAGING
Software 1.8
In Commercial Distribution

  • 03663999000054 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000047

sterEOS workstation
EOS IMAGING
Workstation 1.8
In Commercial Distribution

  • 03663999000047 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000030

sterEOS workstation software
EOS IMAGING
Software 1.6
In Commercial Distribution

  • 03663999000030 ()


  • Basic diagnostic x-ray system application software

sterEOS® - 03663999000023

sterEOS workstation
EOS IMAGING
Workstation 1.6
In Commercial Distribution

  • 03663999000023 ()


  • Basic diagnostic x-ray system application software

EEA - 10884521593176

Black Circular Stapler with Tri-Staple Technology
Covidien LP
TRIEEAXL33XT
In Commercial Distribution

  • 20884521593173 ()
  • 10884521593176 ()

  • Outer Diameter: 33 Millimeter


  • Intraluminal circular stapler, single-use

EEA - 10884521593169

Cellular Stapler with Tri-Staple Technology
Covidien LP
TRIEEAXL33MT
In Commercial Distribution

  • 20884521593166 ()
  • 10884521593169 ()

  • Outer Diameter: 33 Millimeter
  • Medium/Thick XL;


  • Intraluminal circular stapler, single-use
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