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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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EVASOFT - D83399924908000

EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software

NA - 10886704064947

Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
Medos International Sàrl
91-4205US
Not in Commercial Distribution

  • 10886704064947 ()
  • 10886704071426 ()
914205US

  • Infusion pump programmer

Millennium - 00190776205096

STAINLESS STEEL CONE
Avalign Technologies, Inc.
72-135328
In Commercial Distribution

  • 00190776205096 ()


  • Intraluminal circular stapler, reusable

MAR - 00840682134989

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134989 ()


  • CT system application software

ASiR-V - 00840682134972

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134972 ()


  • CT system application software

SnapShot Freeze - 00840682142601

No Description
GE MEDICAL SYSTEMS, INC.
2
In Commercial Distribution

  • 00840682142601 ()


  • CT system application software

DLIR - 00840682146586

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682146586 ()


  • CT system application software

StrokeSENS - B926SSSX10

StrokeSENS LVO is a radiological computer-aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images.
Circle Neurovascular Imaging Inc
v1.x
In Commercial Distribution

  • B926SSSX10 ()


  • CT 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
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