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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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SCIMAGE, INC
3.x
In Commercial Distribution

  • 00861917000305 ()


  • Radiological PACS software
The ANAM® Test System: Military, Military Expanded, Core, Core Expanded, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury. The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions. The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.5.0.7
In Commercial Distribution

  • 00860334002121 ()


  • Psychological assessment software
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions. The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.5
In Commercial Distribution

  • 00860334002114 ()


  • Psychological assessment software
The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The ANAM Military Battery provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions. The ANAM Military Battery provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test results to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Military Battery will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available.
VISTA PARTNERS, LLC
4.3
In Commercial Distribution

  • 00860334002107 ()


  • Psychological 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
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 iSite integrator 14.1
In Commercial Distribution

  • 00863670000332 ()


  • 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 Server 2.2
In Commercial Distribution

  • 00863670000325 ()


  • 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 View/Workstation 2.7
In Commercial Distribution

  • 00863670000301 ()


  • Radiological PACS software
Final software release for UDI-DI: T-2022.03. Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
SYNOPSYS, INC.
S-2021.06 onwards
Not in Commercial Distribution

  • 00863520000390 ()


  • Radiological PACS software
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