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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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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

DRX - Ascend System - 60889971029881

LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution

  • 60889971029881 ()
1029883

  • Basic diagnostic x-ray system application software

Logicon Caries Detector - 60192156851628

LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM DENTAL LLC
Logicon Caries Detector
Not in Commercial Distribution

  • 60192156851628 ()
8008690

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60192155943010

CS IMAGING CLIENT SERVER SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
Not in Commercial Distribution

  • 60192155943010 ()
5943014

  • General-purpose dental x-ray system application software

Logicon Caries Detector - 60192155942754

CSD LOGICON CARIES DETECTOR
CARESTREAM DENTAL LLC
Logicon Caries Detector
In Commercial Distribution

  • 60192155942754 ()
5942750

  • General-purpose dental x-ray system application software

Trophy Imaging 8 - 60192155500688

Trophy Imaging 8
CARESTREAM DENTAL LLC
Trophy Imaging 8
In Commercial Distribution

  • 60192155500688 ()
5500681

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60192155500671

CS IMAGING 8 SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution

  • 60192155500671 ()
5500673

  • General-purpose dental x-ray system application software

CS 3D Imaging Software - 60192155319587

CS 3D IMAGING
CARESTREAM DENTAL LLC
CS 3D Imaging Software
In Commercial Distribution

  • 60192155319587 ()
5319587

  • General-purpose dental x-ray system application software

Dental Imaging Software - 60192155319570

DENTAL IMAGING SOFTWARE
CARESTREAM DENTAL LLC
Dental Imaging Software
In Commercial Distribution

  • 60192155319570 ()
5319579

  • General-purpose dental x-ray system application software

Trophy 3D Imaging - 60192155319556

TROPHY 3D IMAGING
CARESTREAM DENTAL LLC
Trophy 3D Imaging
In Commercial Distribution

  • 60192155319556 ()
5319553

  • General-purpose dental x-ray system application software
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