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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 Class Implantable

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Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Ambra Health
AMBRMOBILEAPP0
In Commercial Distribution

  • AMBRMOBILEAPP0 ()


  • Radiology information system
No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system
No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system
EXAM TABLE W/OUTLET & DRAWER
GF HEALTH PRODUCTS, INC.
4200-DW-WG
In Commercial Distribution

  • M3684200DWWG1 ()


  • Centralized patient monitor
ZENITH 9000 SLIDE WIDE W/LOK
GF HEALTH PRODUCTS, INC.
ZZA99674-897
In Commercial Distribution

  • M368ZZA996748971 ()


  • Centralized patient monitor
BED Z9100 APS W/ LOK SLIDE WIDE
GF HEALTH PRODUCTS, INC.
ZZA99674
In Commercial Distribution

  • M368ZZA996741 ()


  • Centralized patient monitor
BED ZENITH APS SLIDE WIDE 240V
GF HEALTH PRODUCTS, INC.
ZZA9967406
In Commercial Distribution

  • M368ZZA99674061 ()


  • Centralized patient monitor
No Description
CLINICOMP INTERNATIONAL, INC.
FMRD 4K 55"
In Commercial Distribution

  • B321340226010 ()

  • Height: 28 Inch
  • Length: 49 Inch
  • Weight: 42 Pound
340-22601

  • Centralized patient monitor
StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) 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 (L VO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected L VO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of the case earlier that they may have been notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage/ prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.
Circle Cardiovascular Imaging Inc
v2.x
In Commercial Distribution



  • CT system application software
VisionX version 3.0.x
DÜRR DENTAL SE
E7300
In Commercial Distribution

  • E247E7300A10 ()


  • General-purpose dental x-ray system application software
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