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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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Panther TPS 5.81
Prowess, Inc.
5.81
In Commercial Distribution

  • 00859032007231 ()


  • Radiation therapy software
Panther TPS 5.8
Prowess, Inc.
5.8
Not in Commercial Distribution

  • 00859032007200 ()


  • Radiation therapy software
Panther TPS 5.7 DCP2
Prowess, Inc.
5.7
Not in Commercial Distribution

  • 00859032007194 ()


  • Radiation therapy software
Panther TPS 5.7 DCP
Prowess, Inc.
5.7
Not in Commercial Distribution

  • 00859032007170 ()


  • Radiation therapy software
No Description
Prowess, Inc.
5.7
In Commercial Distribution

  • 00859032007132 ()


  • Radiation therapy software
No Description
Prowess, Inc.
v5.6
Not in Commercial Distribution

  • 00859032007064 ()


  • Radiation therapy software
No Description
Prowess, Inc.
version 5.0
Not in Commercial Distribution

  • 00859032007002 ()


  • Radiation therapy software
No Description
Interacoustics A/S
Viot Suite
In Commercial Distribution

  • 05711117199765 ()


  • Camera application software
No Description
Interacoustics A/S
2D-VOGfw
In Commercial Distribution

  • 05711117180497 ()


  • Camera application software
SL Console
MICROLIGHT CORPORATION OF AMERICA
ML-830-07-003
In Commercial Distribution

  • 00859626006282 ()
ML-830-07-003

  • Laser application software
DC Console Activation Card
MICROLIGHT CORPORATION OF AMERICA
ML-830-04-002
In Commercial Distribution

  • 00859626006190 ()
ML-830-04-002

  • Laser application 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
VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000230 ()


  • Radiological PACS software
The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
2.18.2
In Commercial Distribution

  • 00860011623915 ()


  • Radiological PACS 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
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