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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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Torana™ - 00860011623915

The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
2.18.2
In Commercial Distribution

  • 00860011623915 ()


  • Radiological PACS software

Simpleware Medical - 00860011545705

Simpleware Medical image processing. Applicable software versions (UDI-PI) (01)00860011545705(8012)V-2024.06 (01)00860011545705(8012)W-2024.12 (01)00860011545705(8012)X-2025.06
SYNOPSYS, INC.
V-2024.06 -
In Commercial Distribution

  • 00860011545705 ()


  • Radiological PACS software

BrainCheck Assess - 00860011154501

BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment software

UltraGATEWAY - 00860002319803

DICOM Router
ULTRARAD CORPORATION
4.0.10.27
In Commercial Distribution

  • 00860002319803 ()


  • Radiological PACS software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177786

No Description
STRYKER CORPORATION
EMDAN 2.3.1
In Commercial Distribution

  • 00860002177786 ()
910-01957

  • Alarm application software

Engage Medical Device Alert Notification System (EMDAN) - 00860002177779

No Description
STRYKER CORPORATION
910-01947
In Commercial Distribution

  • 00860002177779 ()
910-01947

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177762

No Description
STRYKER CORPORATION
EMDAN 2.5.0
In Commercial Distribution

  • 00860002177762 ()
910-01959

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177755

No Description
STRYKER CORPORATION
EMDAN 2.4.0
In Commercial Distribution

  • 00860002177755 ()
910-01958

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177748

No Description
STRYKER CORPORATION
EMDAN 2.3.0
In Commercial Distribution

  • 00860002177748 ()
910-01956

  • Alarm application software

Engage Medical Device Alarm Notification System (EMDAN) - 00860002177731

No Description
STRYKER CORPORATION
EMDAN 2.1.1
In Commercial Distribution

  • 00860002177731 ()
910-01954

  • Alarm application software
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