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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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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 LaunchPad 2.5
In Commercial Distribution

  • 00863670000318 ()


  • Radiological PACS software
SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
RADIALOGICA LLC
1.x
In Commercial Distribution

  • 00863284000315 ()


  • Radiation therapy software
Standard Imaging QA Pilot is cloud-based software tool that allows users to enter, store, and analyze data accumulated in the clinical radiation oncology setting from quality assurance processes.
STANDARD IMAGING INC.
91348
In Commercial Distribution

  • 00866562000298 ()
91348

  • Radiation therapy 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
Blackford Platform v3.0.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
3.0.x
In Commercial Distribution

  • 05060570830150 ()


  • Radiological PACS software
Blackford Platform v2.4.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.4.x
In Commercial Distribution

  • 05060570830112 ()


  • Radiological PACS software
Blackford Smart Localizer v1.4.x, supplied with Blackford Platform (part of the Blackford Product Family)- previously marketed as the Blackford Registration Application, released under evaluation only.
BLACKFORD ANALYSIS LIMITED
1.4.x
In Commercial Distribution

  • 05060570830105 ()


  • Radiological PACS software
Blackford Platform v2.3.x, supplied with Blackford Smart Localizer (part of the Blackford Product Family)
BLACKFORD ANALYSIS LIMITED
2.3.x
In Commercial Distribution

  • 05060570830099 ()


  • Radiological PACS software
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