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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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No Description
COGNIVUE, INC.
Desktop Unit
In Commercial Distribution

  • 00860000564014 ()


  • Cognitive assessment software
No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution

  • 00860000564007 ()


  • Cognitive assessment software
A software application that allows post-capture positioning and joining of individual images, to produce an additional composite image for a two-dimensional image review.
OSKO, INC.
Smart Stitching
In Commercial Distribution

  • 00869126000451 ()


  • Radiological PACS software
The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard “off-the-shelf” personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet.
Fujifilm Healthcare Americas Corporation
4.X.X
In Commercial Distribution

  • 00869047000431 ()


  • Radiological PACS software
No Description
INTOUCH TECHNOLOGIES, INC.
InTouch Imaging
In Commercial Distribution

  • 00868772000174 ()


  • Radiological PACS software
The purpose of Prowess Panther TPS is to provide a complete program for radiation therapy treatment planning. This includes computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides data in the form of display, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. Panther treatment planning system allows radiation physicians, physicists, and dosimetrists to optimize the delivery of radiation in treating cancer and related diseases.
Prowess, Inc.
version 5.51
Not in Commercial Distribution

  • 00868603000236 ()


  • Radiation therapy software
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 17
Cercare Medical A/S
17
In Commercial Distribution

  • 05745000308279 ()


  • Radiological PACS software
Cercare Medical Neurosuite with Capillary Function ver. 17
Cercare Medical A/S
17
In Commercial Distribution

  • 05745000308262 ()


  • Radiological PACS software
Cercare Medical Neurosuite ver. 17
Cercare Medical A/S
17
In Commercial Distribution

  • 05745000308255 ()


  • Radiological PACS software
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 16
Cercare Medical A/S
16
In Commercial Distribution

  • 05745000308224 ()


  • Radiological PACS software
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