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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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eRAD PACS v7.2
Erad, Inc.
7.2
In Commercial Distribution

  • 00866994000200 ()


  • Radiological PACS software
Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems.
STANDARD IMAGING INC.
v1
In Commercial Distribution

  • 00866562000243 ()
91350

  • Radiation therapy software
Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
STANDARD IMAGING INC.
v3
In Commercial Distribution

  • 00866562000229 ()
91326

  • Radiation therapy software
The Radiation Analyzer (RAy)is a film dosimetry application used to verify complex radiation therapy treatment plans.
AGILE RADIOLOGICAL TECHNOLOGIES
5.0
Not in Commercial Distribution

  • 00866498000300 ()
Ray 5.0

  • Radiation therapy software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution

  • 00864127000356 ()


  • Cognitive assessment software
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.
IMPACT APPLICATIONS, INC.
4
In Commercial Distribution

  • 00864127000349 ()


  • Cognitive assessment software
No Description
IMPACT APPLICATIONS, INC.
1
In Commercial Distribution

  • 00864127000332 ()


  • Cognitive assessment software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
1
Not in Commercial Distribution

  • 00864127000325 ()


  • Cognitive assessment software
Web-based dental Picture Archiving and Communications System (PACS)
REALCLOUD IMAGING, INC.
1
In Commercial Distribution

  • 00864058000302 ()


  • Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
IMORGON MEDICAL LLC
Imorgon Report Accelerator 1.4
In Commercial Distribution

  • 00863670000349 ()


  • Radiological PACS software
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