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

  • 00860011154501 ()


  • Cognitive assessment software
No Description
Anthrotronix, Inc.
1.0
In Commercial Distribution

  • 00860011042105 ()


  • Cognitive assessment software
A collection of neuropsychological tests for health professionals and researchers. The assessment measures cognitive function and performs a complete cognitive screening, allowing users to quickly, conveniently, and accurately assess the well-being and cognitive profile of patients and research participants. Applicable via in-person consultation, in a laboratory setting, and remotely.
Cognifit, Inc.
PRO
In Commercial Distribution

  • 00860009958104 ()


  • Cognitive assessment software
CNS Vital Signs cognitive testing installed local software platform. A set of cognitive tests and clinical questionnaires administered in office without an internet connection.
CNS Vital Signs, LLC
4.0.107
In Commercial Distribution

  • 00860013886110 ()


  • Psychological assessment software
No Description
VARIAN MEDICAL SYSTEMS, INC.
18.1
In Commercial Distribution

  • 00855141006349 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
18.0
In Commercial Distribution

  • 00855141006202 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
17.0
In Commercial Distribution

  • 00855141006103 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
16.1
In Commercial Distribution

  • 00855141006080 ()


  • Radiation therapy software
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