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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
Agfa HealthCare NV
8.1.2
Not in Commercial Distribution

  • 05414904252437 ()
XFNCQ

  • Radiological PACS software
No Description
Agfa HealthCare NV
8.1.1
Not in Commercial Distribution

  • 05414904242919 ()
XDFO2

  • Radiological PACS software
No Description
Agfa HealthCare NV
8.1.1
Not in Commercial Distribution

  • 05414904242902 ()
XDFNZ

  • Radiological PACS software
ENT IMG SW XERO VIEWER 8.1
Agfa HealthCare NV
Enterprise Imaging Xero Viewer 8.1
Not in Commercial Distribution

  • 05414904218532 ()
5873H

  • Radiological PACS software
ENT IMG SW 8.
Agfa HealthCare NV
Enterprise Imaging Desktops 8.1
Not in Commercial Distribution

  • 05414904218525 ()
5872F

  • Radiological PACS software
IMPAX SW CLIENT V6.7
Agfa HealthCare NV
IMPAX 6.7
Not in Commercial Distribution

  • 05414904216552 ()
58B5Y

  • Radiological PACS 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
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
No Description
VARIAN MEDICAL SYSTEMS, INC.
16.0
In Commercial Distribution

  • 00855141006073 ()


  • Radiation therapy software
No Description
Varian Medical Systems Finland Oy
15.6
In Commercial Distribution

  • 00855141006066 ()


  • Radiation therapy software
No Description
Varian Medical Systems Finland Oy
15.5
In Commercial Distribution

  • 00855141006059 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1.1
In Commercial Distribution

  • 00855141006042 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
13.6
In Commercial Distribution

  • 00855141006035 ()


  • Radiation therapy software
No Description
VARIAN MEDICAL SYSTEMS, INC.
15.1
In Commercial Distribution

  • 00855141006028 ()


  • Radiation therapy software
No Description
Varian Medical Systems Finland Oy
15.0
In Commercial Distribution

  • 00855141006011 ()


  • Radiation therapy software
No Description
Varian Medical Systems Finland Oy
13.7
In Commercial Distribution

  • 00855141006004 ()


  • Radiation therapy software
CNS Vital Signs cognitive testing web platform. A limited set of cognitive tests and clinical questionnaires with audio instructions that can be administered in office.
CNS Vital Signs, LLC
1.1.4
In Commercial Distribution

  • 00860013886134 ()


  • Psychological 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
CNS Vital Signs cognitive testing web platform. A set of cognitive tests and clinical questionnaire that can be administered in office or remotely.
CNS Vital Signs, LLC
2.0.6
In Commercial Distribution

  • 00860013886103 ()


  • Psychological assessment software
No Description
Spark Neuro Inc.
SP010000
In Commercial Distribution

  • 00860011882022 ()


  • Cognitive assessment 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
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