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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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EVA SELECT - D83399924121050

EVA SELECT SIZE 1 SENSOR
ImageWorks
9992412105
In Commercial Distribution

  • D83399924121050 ()
9992412105

  • General-purpose dental x-ray system application software

Optellum Virtual Nodule Clinic - B816VNC2P30

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
2.3
In Commercial Distribution

  • B816VNC2P30 ()
N/A

  • CT system application software

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

Spectral Color Overlay - 00195278630384

Spectral Color Overlay MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278630384 ()
5929649

  • CT system application software

Spectral Bone Marrow - 00195278630377

Spectral Bone Marrow MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278630377 ()
5929650

  • CT system application software

Head Auto Views - 00195278629586

Head Auto Views MD Application Container for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278629586 ()
5929651

  • CT system application software

DLIR - 00195278620453

SWMD DLIR Application for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.2
In Commercial Distribution

  • 00195278620453 ()
5928863

  • CT system application software

Spine Auto Views - 00195278534064

Spine Auto Views Medical Device
GE MEDICAL SYSTEMS
See CODE part
In Commercial Distribution

  • 00195278534064 ()


  • CT system application software

SnapShot Freeze 2 - 00195278865335

SnapShot Freeze Medical Device
GE MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00195278865335 ()
5963072

  • CT system application software

MAR - 00195278303219

MAR Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution

  • 00195278303219 ()


  • CT system application software
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